NCT04284059 is a Phase 4 clinical trial of vitamin AD in ADHD, sponsored by Chen Li.

Who is sponsoring NCT04284059?

NCT04284059 is sponsored by Chen Li.

What drugs are being tested in NCT04284059?

Interventions in NCT04284059: Placebos, vitamin AD, vitamin D.

Is NCT04284059 still recruiting?

NCT04284059 is currently status unknown. Last updated 6 April 2021.

Last reviewed 2021-04-06 · How we verify

NCT04284059

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD

Status unknown Phase 4 Last updated 6 April 2021

What this trial tests

Phase 4 trial testing Placebos in ADHD in 504 participants. Status unknown.

Timeline

25 February 2021

Primary endpoint
30 May 2022

30 August 2022

Quick facts

Lead sponsor	Chen Li
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	504
Start date	25 February 2021
Primary completion	30 May 2022
Estimated completion	30 August 2022
Sites	3 locations across China

Drugs / interventions tested

Placebos — full drug profile →
vitamin AD
vitamin D

Conditions studied

ADHD — all drugs for ADHD →

Sponsor

Chen Li

Who can join

Adults 6 to 12, any sex, with ADHD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Around 7.2% of children around the world are suffering from ADHD. On account of current medical treatment, a high remission rate can be reached for ADHD. Nevertheless, patients have to face a number of side effects associated with the treatment. It was informed that patients of ADHD have a tendency to vitamin A and vitamin D deficiency. The aim of the study is to determine the effect of vitamin A and vitamin D supplementation as adjunctive therapy to methylphenidate on symptoms of ADHD. 504 subjects aged 6-12 years with a diagnosis of ADHD based on DSM-5 criteria are randomly assigned into three groups to receive vitamin A 6000 IU/day and vitamin D 2100 IU/day, or vitamin D 2100 IU/day or placebo adding to methylphenidate for 8 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales and Questionnaire - Children with Difficulties at weeks 0, 4, and 8. Serum levels of retinol and 25(OH)D are measured at baseline and after 8 weeks. All the other sociodemographic data are assessed. The study can give more references on the application of vitamin A and vitamin D in addition to methylphenidate to ADHD. Future research is needed to clarify mechanism of vitamin A and vitamin D on ADHD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Adjuvant effects of vitamin A and vitamin D supplementation on treatment of children with attention-deficit/hyperactivity disorder: a study protocol for a randomised, double-blinded, placebo-controlled, multicentric trial in China.
Zhou P, Wolraich ML, Cao AH, Jia FY, et al · · 2021 · cited 7× · PMID 34135055 · DOI 10.1136/bmjopen-2021-050541

Verify or expand the search:

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Other Chen Li trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04284059 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chen Li
Last refreshed: 6 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04284059.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing