Saffron for Children: A Review of the Published Clinical Trials

Published by Triquetra Health, which manufactures a liquid saffron extract for children. This review covers the published literature on saffron as an ingredient and is written to be useful regardless of which product a practitioner considers.

Saffron (Crocus sativus) has a small but growing body of published human research in children and adolescents. As of 2026 it comprises four clinical trials and one peer-reviewed systematic review. The largest pediatric dataset is a three-month prospective, non-randomized study of the branded Saffr’Activ® extract at 30 mg/day in ages 7–17 (saffron arm: 36 enrolled, 32 completed). Blinded evidence comes from two randomized, double-blind trials against methylphenidate in ages 6–17 at 20–30 mg/day, and one randomized, double-blind, placebo-controlled trial in ages 12–16 at 28 mg/day.

Combined enrollment across the four trials is 275, of whom 244 completed. Studied pediatric doses cluster at 20–30 mg/day of standardized extract. Every published pediatric trial enrolled children with diagnosed ADHD or with mild-to-moderate anxiety or depressive symptoms. None enrolled a general-wellness population, and none enrolled a child under 6. Those two gaps are the most important limitations for practitioners to weigh.

 

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What is saffron, and which compounds are biologically active?

Saffron is the dried stigma of the Crocus sativus flower. Three apocarotenoid families account for most of its studied pharmacology, and they behave differently enough that knowing which one a label refers to tells you a fair amount about the product.

Crocins

Crocins are the glycosylated carotenoid esters responsible for saffron’s color. They are the compound class most supplement labels standardize to, and the one most trials quantify. They are also water-soluble and heat-labile, which matters for processing: crocin content degrades under high-temperature drying, so two extracts from identical raw material can differ substantially depending on how the liquid extract was dried.

Safranal

Safranal is the volatile aldehyde behind saffron’s aroma, formed largely by degradation of picrocrocin during drying and storage. It is the compound most often associated with GABAergic activity in preclinical work. Safranal is genuinely difficult to quantify well, and the analytical method used changes the reported number substantially.

Picrocrocin

Picrocrocin is the bitter glycoside that serves as safranal’s precursor. It is rarely a standardization target, but its ratio to crocins is used analytically as an authenticity marker, because adulterated material tends to show ratios outside the natural range.

Why grade and standardization change the bioactive load

Two variables move the actual bioactive content of a saffron product more than anything printed on the front of the bottle.

The first is grade. Sargol grade consists of all-red stigma tips with the pale style removed. Lower grades include style material, which contributes mass without contributing apocarotenoids. A per-milligram dose from a style-inclusive grade is not equivalent to the same milligram figure from Sargol.

The second is analytical method. UV spectrophotometry measures total absorbance in a wavelength band, so anything else absorbing in that band gets counted. Because saffron is among the most frequently adulterated botanicals on the market, and common adulterants are chosen precisely because they mimic its absorbance, UV can overstate content considerably. HPLC separates and quantifies individual crocins, so it reports what is actually present.

The gap this produces is not academic. For safranal in particular, UV and HPLC figures for the same material can differ by more than an order of magnitude. Both numbers can be accurate under their respective methods. Only one of them tells you what is in the bottle. This is why the right question to a supplier is never “what percentage?” but “what percentage, by which method?”

 

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What clinical evidence exists for saffron in children?

How large is the pediatric evidence base?

Four published clinical trials have studied standardized saffron extract in participants under 18, with a combined enrollment of 275 and 244 completers. One is placebo-controlled. Three used methylphenidate as an active comparator, two of them without a placebo arm. One was neither randomized nor blinded. A single peer-reviewed systematic review has synthesized part of this literature.

For context, that is a smaller evidence base than most practitioners would consider adequate for a confident clinical recommendation, and the review authors say so directly. What follows describes each trial on its own terms.

 

 

The Saffr’Activ® prospective study, ages 7–17

Blasco-Fontecilla et al. (Nutrients, 2022) is the only published clinical study of the Saffr’Activ® extract in a pediatric population, which makes it the sole source of formulation-specific pediatric evidence for that ingredient. Participants were medication-naïve outpatients recruited through a hospital child and adolescent mental health service, all meeting DSM-5 criteria for ADHD confirmed by a child psychiatrist. The saffron arm received 30 mg/day for three months.

Across the study population, statistically significant pre-to-post improvements appeared on parent-rated inattention (p < 0.001), total symptom score (p = 0.011), an abbreviated parent rating scale (p = 0.001), and a parent-rated executive function inventory (p < 0.001), plus two objective continuous-performance measures (response style p = 0.001; commission errors p < 0.001).

Four limitations deserve equal weight with those results. The study was not randomized and not blinded, and participants chose their own treatment arm, which leaves it open to selection bias the authors themselves flag. The improvements above were observed across both arms rather than as a between-arm difference; every group-by-treatment interaction was non-significant. The hyperactivity subscale showed no significant treatment effect (p = 0.688). And the sleep outcomes did not reach significance on either sub-measure (sleep hours p = 0.213; time to fall asleep p = 0.493).

The randomized, double-blind trials, ages 6–17

Baziar et al. (Journal of Child and Adolescent Psychopharmacology, 2019) randomized 54 children ages 6–17 with ADHD to saffron or methylphenidate, dosed by body weight at 20 mg/day under 30 kg and 30 mg/day above, for six weeks. Fifty completed. Outcomes were parent- and teacher-rated. The trial reported no statistically significant difference between the two arms.

The design point matters more than the result. With no placebo arm, an active-comparator trial cannot isolate the ingredient’s effect. Both groups improving similarly is compatible with both treatments working, both producing expectation effects, or natural course. This trial adds blinding rigor to the ingredient-class picture; it does not establish efficacy against placebo.

Khaksarian et al. (Iranian Journal of Psychiatry and Behavioral Sciences, 2021) used an add-on design in children ages 6–16 with ADHD, comparing methylphenidate alone against methylphenidate plus saffron at 20–30 mg/day by weight, over eight weeks. Seventy-eight were randomized and 70 completed. The combination arm showed greater improvement at weeks 4 and 8. The same interpretive limit applies, with an additional one: an add-on trial measures incremental effect on top of an existing therapy, which is a different question from standalone effect.

The placebo-controlled adolescent trial, ages 12–16

Lopresti et al. (Journal of Affective Disorders, 2018) is the only randomized, double-blind, placebo-controlled trial of a branded saffron extract in a pediatric age range. It used a different branded extract at 14 mg twice daily for eight weeks in adolescents ages 12–16 with mild-to-moderate anxiety or depressive symptoms. Eighty participants enrolled and 68 completed.

Youth self-report showed significant improvements on overall internalizing symptoms (p = 0.049), separation anxiety (p = 0.003), social phobia (p = 0.023), and depression (p = 0.016), with total internalizing scores falling 33% versus 17% on placebo (p = 0.029). Parent-rated totals also improved significantly, 40% versus 26% (p = 0.026), but no other parent-report measure reached significance. The authors characterize parental corroboration as inconsistent, which is the accurate summary.

Two features distinguish this trial from the three above: it is placebo-controlled, and it enrolled adolescents on the basis of symptom scores rather than a specialist diagnosis. It is also the only pediatric-age trial in the set that did not involve a prescription comparator.

The placebo-controlled sleep trial, adults

Pachikian et al. (Nutrients, 2021) supplemented 66 adults presenting mild-to-moderate sleep disturbance associated with anxiety with the Saffr’Activ® extract at 15.5 mg/day for six weeks, using actigraphy alongside validated questionnaires. The saffron group showed improvements in sleep quality, time to fall asleep, and sleep duration versus placebo, which did not change on those parameters.

This is the most methodologically robust trial on the branded extract. It is also adult and symptomatic, so it establishes nothing directly about children. Notably, the pediatric sleep signal points the other way: the sleep outcomes in Blasco-Fontecilla did not reach significance.

What the systematic review concluded

Seyedi-Sahebari et al. (Journal of Attention Disorders, 2024) pooled four trials comprising 227 participants, of whom 118 received saffron, across children, adolescents, and adults, assessing risk of bias with ROBINS-I. It found saffron performed comparably to methylphenidate as monotherapy and added benefit as an adjunct, with no significant safety concerns identified. The authors call for larger multicenter studies. The evidence base being summarized is small, and the review does not obscure that.

Funding and conflicts of interest

Practitioners evaluating this literature should know the following, because neither study of the branded extract is independent of the ingredient supplier.

The Blasco-Fontecilla study discloses that Masso Laboratories financed the insurance required to run the study and provided the saffron extract at no cost. Its lead author separately discloses that he is co-founder and CEO of a company that markets a food supplement containing saffron. The Pachikian sleep trial was funded by Comercial Química Massó, part of the same supplier group, and the published funding statement notes the funder participated in study design and in preparation of the manuscript.

Supplier funding does not invalidate a trial. It does mean the findings warrant the same scrutiny you would apply to any industry-sponsored research, and that independent replication has not yet occurred for this extract.

What this literature does not yet show

Four gaps are worth stating plainly.

• No trial has enrolled a child under 6. The youngest participant in any published saffron trial is 6 years old.
• No trial has enrolled a general-wellness pediatric population. The closest is Lopresti’s symptom-screened adolescent sample.
• No placebo-controlled trial exists in children under 12. The one placebo-controlled pediatric-age trial started at age 12.
• No independent replication of the branded-extract findings exists. Both Saffr’Activ® trials share supplier funding.

 

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How does saffron work?

Everything in this section is preclinical. None of these mechanisms has been demonstrated in a human trial, and they should be described to patients and colleagues as proposed mechanisms rather than established effects.

Monoamine reuptake

Review literature reports that crocins and safranal inhibit reuptake of dopamine, norepinephrine, and serotonin in animal and cell-culture models (Khazdair et al., Avicenna Journal of Phytomedicine, 2015). This is the mechanism most often cited to explain why one botanical is investigated across attention, mood, and sleep outcomes. The underlying evidence is entirely non-human.

GABA-A modulation

Safranal has been reported to interact with GABA-A receptor complexes in preclinical models, which is the proposed basis for the sedative and anxiolytic effects observed in animal work.

Glutamatergic and NMDA activity

Berger, Hensel, and Nieber (Neuroscience, 2011) documented that saffron extract and trans-crocetin inhibit glutamatergic synaptic transmission in rat cortical brain slices. Trans-crocetin also shows affinity for the NMDA receptor. Worth keeping analytically separate: glutamate is not a monoamine, so this is a distinct pathway rather than an extension of the reuptake mechanism above, and conflating the two is a common error in supplement marketing copy.

The crocin to trans-crocetin absorption relay

This is the best-characterized part of saffron’s pharmacokinetics and the one that explains an otherwise puzzling result: crocins are poorly absorbed intact, yet saffron shows central activity in animal models.

Lautenschläger et al. (Phytomedicine, 2015) determined, using Caco-2 monolayers and two porcine blood-brain-barrier models, that crocin-1 does not cross the intestinal barrier in meaningful quantities even at high concentrations. Intestinal epithelial cells deglycosylate crocins to lipophilic trans-crocetin, which then permeates by passive transcellular diffusion, with roughly 32% transported within two hours. Trans-crocetin subsequently crosses both blood-brain-barrier models slowly but steadily, and it is also a P-glycoprotein efflux substrate. Conversion occurs mainly in intestinal cells rather than through colonic microbial fermentation.

What this work establishes is a plausible route by which orally administered crocins could reach the central nervous system. It does not measure central activity in people, and it does not quantify how much reaches the brain at supplement doses.

 

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What doses of saffron have been studied, and at what ages?

 

 

Published pediatric doses cluster tightly at 20–30 mg/day of standardized extract, with two trials scaling by body weight at a 30 kg threshold.

Body-weight scaling below age 7

Products dosed below age 6 are extrapolating, and practitioners should treat them that way. Two extrapolation routes are in use: linear body-weight scaling from the pediatric 20–30 mg range, and reference to adult trials conducted at comparable absolute doses, such as the 15.5 mg/day sleep trial. Neither is a substitute for a trial in that age band, and linear scaling in particular is a rough instrument in young children, where organ maturation rather than mass often governs clearance.

How studied doses compare to safety-evaluation doses

The 20–30 mg/day pediatric range sits roughly 7- to 13-fold below the 200–400 mg/day doses used in short-term adult safety evaluation. That margin is meaningful but should not be overstated: it derives from adult data, and it has not been characterized in children.

 

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Is saffron safe for children?

Reported tolerability in the pediatric trials

Across the published pediatric trials and the systematic review, no significant safety concerns were identified. In the Blasco-Fontecilla study, 31.2% of the saffron arm reported side effects, and the authors characterized the treatment as well tolerated. Because that study had no placebo arm, this rate cannot be attributed to saffron specifically; a placebo-controlled design would be required to separate treatment-emergent effects from background reporting.

What adult safety research shows

Modaghegh et al. (Phytomedicine, 2008) evaluated saffron in 30 healthy adults across three arms of ten, at placebo, 200 mg/day, and 400 mg/day for seven days. At 400 mg, standing systolic blood pressure and mean arterial pressure decreased significantly. Small decreases appeared in red blood cell count, hemoglobin, hematocrit, and platelet count, and sodium, blood urea nitrogen, and creatinine rose across dose arms. The authors concluded the observed changes remained within normal ranges and were not clinically important.

Three qualifications on that study: ten participants per arm is a thin base, seven days says nothing about chronic use, and the population was adult.

Medication and interaction considerations

Saffron’s hematologic parameters warrant attention in patients on anticoagulant or antiplatelet therapy, but the direction and clinical significance of any such interaction is unestablished. The available data are limited to small, short-term adult studies, the observed changes were within normal ranges, and no interaction has been characterized in children or in patients taking these medications. Practitioners should exercise clinical judgment on that basis rather than on an assumed additive effect.

Given the preclinical monoamine and GABAergic activity described earlier, concurrent psychotropic medication also warrants clinical judgment, though again no interaction has been characterized in human trials.

Heavy metals, adulteration, and why saffron is a high-fraud botanical

Saffron is among the world’s most expensive spices by weight, which makes it among the most frequently adulterated. Common adulterants include safflower, turmeric, marigold, dyed plant material, and synthetic colorants selected specifically because they mimic saffron’s absorbance profile, which is what defeats UV-only testing.

For pediatric use this converts an economic problem into a safety one. Adulterants are unquantified, unlabeled, and untested in children. Practitioners should treat verified origin, HPLC-based standardization, and an accessible heavy-metals certificate of analysis as safety requirements rather than quality niceties.

Who should exercise particular caution

Children taking anticoagulant or antiplatelet therapy. Children on psychotropic medication. Children under 6, for whom no trial data exists. For adolescent patients, saffron has documented uterine effects at high doses in the traditional and preclinical literature, which is worth knowing even though it is not directly relevant to a pediatric population.

 

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How should you evaluate a pediatric saffron product?

The criteria below apply to any product in this category. Apply them yourself rather than accepting a manufacturer’s summary.

 

 

Two criteria are worth weighting above the others for pediatric use specifically: formulation-specific evidence in the actual age band you are dosing, and the analytical method behind the standardization figure. Those two questions eliminate most of the category quickly.

 

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Product specifications: SaffronRX® Kids Formula

The publisher of this review manufactures the product below. Specifications are provided so the evaluation criteria above can be applied to it directly. It is not offered for any of the conditions studied in the cited literature.

SaffronRX® Kids Formula is a single-ingredient liquid saffron extract from Triquetra Health, formulated for pediatric administration.

Extract. Saffr’Activ® Organic Saffron Extract (Crocus sativus L. stigma, Sargol grade) — the branded extract used in Blasco-Fontecilla et al. (2022) and Pachikian et al. (2021).

Serving by age band.

 

Daily Value not established.

The 30 mg serving matches the dose used in the published pediatric study of this extract, which enrolled children ages 7–17. The 15 mg serving is body-weight-scaled. No clinical trial has evaluated this extract, or any saffron extract, in children under 6. Practitioners should apply independent clinical judgment before recommending it below age 7, and parents should consult their child’s pediatrician.

Format. Alcohol-free, sugar-free liquid glycerite with a calibrated dropper, in a 1 fl oz (30 mL) amber bottle. Natural berry flavor. Administered under the tongue or in a small volume of milk, water, or a smoothie. A glycerin base rather than an ethanol tincture is the relevant distinction for pediatric administration.

Other ingredients. Organic vegetable glycerin, reverse osmosis water, and organic berry flavor (organic acacia gum, natural flavors, and citric acid).

Standardization. Minimum 3% crocins by HPLC, quantified using the supplier’s published HPLC-DAD method (Suchareau et al., Food Chemistry, 2021).

Quality documentation. cGMP manufactured. Heavy metals tested by ICP-MS. Non-GMO. USDA Organic, certified by Oregon Tilth. [LINK: current Certificate of Analysis] Testing laboratory: [NAME]. [LINK: USDA Organic Integrity Database operation record.]

What it is and is not. SaffronRX® Kids  Formula is a dietary supplement intended to support normal physiological function in healthy children and teens. It is not a treatment for any condition, and it is not intended to replace medical evaluation. Store out of reach of young children.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

 

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Frequently asked questions

Is there clinical evidence for saffron in children?

Yes, though the evidence base is small. Four published clinical trials and one systematic review have examined standardized saffron extract in children and adolescents, at doses of 20–30 mg/day over six weeks to three months, with a combined enrollment of 275. One trial was placebo-controlled in adolescents ages 12–16; two were randomized and double-blind against an active prescription comparator without a placebo arm; the largest pediatric dataset was prospective but neither randomized nor blinded. Every trial enrolled diagnosed or symptomatic children rather than a general-wellness population, and none enrolled a child under 6. Reviewers have consistently called for larger multicenter trials.

What dose of saffron has been studied in children?

Published pediatric trials used 20–30 mg/day of standardized saffron extract, in two cases scaled by body weight at a 30 kg threshold. No published trial has evaluated saffron in children under age 6. Doses for that band are extrapolated from body-weight scaling and from adult research at comparable doses. Practitioners should individualize and treat the under-7 band as an extrapolation rather than a studied dose.

Is saffron safe for children?

Across published pediatric trials and one systematic review, no significant safety concerns were identified, and reviewers described tolerability as favorable. In the largest pediatric study, 31.2% of the saffron group reported side effects; because that study had no placebo arm, the rate cannot be attributed to saffron specifically. Studied supplement doses of 20–30 mg/day sit roughly 7- to 13-fold below the 200–400 mg/day short-term adult doses at which small changes in blood pressure and several biochemical parameters have been documented, all of which the study authors concluded remained within normal ranges. Practitioners should individualize recommendations and review concurrent medications, particularly anticoagulant, antiplatelet, and psychotropic therapy.

How does saffron work?

Saffron’s apocarotenoids, principally crocins, crocetin, and safranal, have been reported in preclinical models to influence monoamine reuptake, GABA-A signaling, and glutamatergic transmission. In vitro work using intestinal and blood-brain-barrier models shows that poorly absorbed crocins are deglycosylated to lipophilic trans-crocetin, which crosses both barriers by passive diffusion. These mechanisms are characterized in animal and cell-culture models rather than human trials, and should be described as proposed mechanisms rather than demonstrated human effects.

What is Sargol-grade saffron, and why does grade matter?

Sargol refers to saffron consisting of the all-red stigma tips with the pale style removed, which concentrates the bioactive apocarotenoids relative to lower grades containing style material. Because saffron is among the most frequently adulterated botanicals, grade disclosure, verified origin, and analytical standardization are meaningful quality signals.

What’s the difference between HPLC and UV standardization?

UV spectrophotometry measures total absorbance and can overstate content when other absorbing compounds or adulterants are present. HPLC separates and quantifies individual crocins, giving a more specific measure of the actual bioactive load. For safranal in particular, UV and HPLC figures for the same material can differ by more than an order of magnitude. Ask for the method alongside the percentage.

Is saffron a stimulant?

Saffron is not a pharmaceutical stimulant and is not a controlled substance. It is a culinary and dietary botanical. Readers should know that the authors of the largest pediatric saffron study describe the extract as “a natural stimulant” in the pharmacological sense of the term, and preclinical work reports monoamine activity, so the phrase does appear in the literature. That is a different claim from stimulant medication.

How long does saffron take to work?

Published trials assessed outcomes between three weeks and three months rather than acutely. Any effects would be expected to develop gradually with consistent daily use. Individual responses vary.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

 

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Scientific references and citations

The studies below investigated saffron in diagnosed or symptom-screened clinical populations. They are cited to characterize the current state of the published literature and do not describe any use of the product referenced in this review.

Baziar, S., Aqamolaei, A., Khadem, E., Mortazavi, S. H., Naderi, S., Sahebolzamani, E., Mortezaei, A., Jalilevand, S., Mohammadi, M.-R., Shahmirzadi, M., & Akhondzadeh, S. (2019). Crocus sativus L. versus methylphenidate in treatment of children with attention-deficit/hyperactivity disorder: A randomized, double-blind pilot study. Journal of Child and Adolescent Psychopharmacology, 29(3), 205–212. https://doi.org/10.1089/cap.2018.0146

Berger, F., Hensel, A., & Nieber, K. (2011). Saffron extract and trans-crocetin inhibit glutamatergic synaptic transmission in rat cortical brain slices. Neuroscience, 180, 238–247. https://doi.org/10.1016/j.neuroscience.2011.02.037

Blasco-Fontecilla, H., Moyano-Ramírez, E., Méndez-González, O., Rodrigo-Yanguas, M., Martin-Moratinos, M., & Bella-Fernández, M. (2022). Effectivity of saffron extract (Saffr’Activ) on treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD): A clinical effectivity study. Nutrients, 14(19), 4046. https://doi.org/10.3390/nu14194046

Funding disclosure: study product and insurance funding provided by Masso Laboratories. Lead author discloses an ownership interest in a company marketing a saffron-containing supplement.

Khaksarian, M., Ahangari, N., Masjedi-Arani, A., Mirr, I., Jafari, H., Kordian, S., Nooripour, R., & Hassanvandi, S. (2021). A comparison of methylphenidate (MPH) and combined methylphenidate with Crocus sativus (saffron) in the treatment of children and adolescents with ADHD: A randomized, double-blind, parallel-group, clinical trial. Iranian Journal of Psychiatry and Behavioral Sciences, 15(3), e108390. https://doi.org/10.5812/ijpbs.108390

Khazdair, M. R., Boskabady, M. H., Hosseini, M., Rezaee, R., & Tsatsakis, A. M. (2015). The effects of Crocus sativus (saffron) and its constituents on nervous system: A review. Avicenna Journal of Phytomedicine, 5(5), 376–391. https://doi.org/10.22038/AJP.2015.4503

Lautenschläger, M., Sendker, J., Hüwel, S., Galla, H.-J., Brandt, S., Düfer, M., Riehemann, K., & Hensel, A. (2015). Intestinal formation of trans-crocetin from saffron extract (Crocus sativus L.) and in vitro permeation through intestinal and blood brain barrier. Phytomedicine, 22(1), 36–44. https://doi.org/10.1016/j.phymed.2014.10.009

Lopresti, A. L., Drummond, P. D., Inarejos-García, A. M., & Prodanov, M. (2018). affron®, a standardised extract from saffron (Crocus sativus L.) for the treatment of youth anxiety and depressive symptoms: A randomised, double-blind, placebo-controlled study. Journal of Affective Disorders, 232, 349–357. https://doi.org/10.1016/j.jad.2018.02.070

Modaghegh, M.-H., Shahabian, M., Esmaeili, H.-A., Rajbai, O., & Hosseinzadeh, H. (2008). Safety evaluation of saffron (Crocus sativus) tablets in healthy volunteers. Phytomedicine, 15(12), 1032–1037. https://doi.org/10.1016/j.phymed.2008.06.003

Office of Environmental Health Hazard Assessment. (2025). Proposition 65 no significant risk levels (NSRLs) and maximum allowable dose levels (MADLs). California Environmental Protection Agency. https://oehha.ca.gov/proposition-65/general-info/proposition-65-no-significant-risk-levels-nsrls-and-maximum-allowable-dose-levels-madls

Pachikian, B. D., Copine, S., Suchareau, M., & Deldicque, L. (2021). Effects of saffron extract on sleep quality: A randomized double-blind controlled clinical trial. Nutrients, 13(5), 1473. https://doi.org/10.3390/nu13051473

Funding disclosure: funded by Comercial Química Massó, which participated in study design and manuscript preparation.

Seyedi-Sahebari, S., Farhang, S., Araj-Khodaei, M., Akhondzadeh, S., Naseri, A., Sanaie, S., & Frounchi, N. (2024). The effects of Crocus sativus (saffron) on ADHD: A systematic review. Journal of Attention Disorders, 28(1), 14–24. https://doi.org/10.1177/10870547231203176

Suchareau, M., Bordes, A., & Lemée, L. (2021). Improved quantification method of crocins in saffron extract using HPLC-DAD after qualification by HPLC-DAD-MS. Food Chemistry, 362, 130199. https://doi.org/10.1016/j.foodchem.2021.130199

U.S. Department of Agriculture, Agricultural Marketing Service. (n.d.). Organic Integrity Database. https://organic.ams.usda.gov/integrity/

Research quality note

The pediatric saffron literature comprises four clinical trials with a combined enrollment of 275 participants and 244 completers. One is placebo-controlled; two are randomized and double-blind against an active prescription comparator with no placebo arm; one is prospective, non-randomized, and non-blind with self-selected treatment allocation. Three enrolled children with diagnosed ADHD recruited through specialist services; the fourth enrolled adolescents screened on symptom scores.

No published trial has enrolled a child under 6, a general-wellness pediatric population, or provided placebo-controlled evidence in children under 12. The two trials of the Saffr’Activ® extract share funding from the ingredient supplier and have not been independently replicated. All mechanistic findings described in this review derive from animal and cell-culture models rather than human trials.