Status:
UNKNOWN
Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD
Lead Sponsor:
Chen Li
Conditions:
ADHD
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
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 o...
Detailed Description
1. Procedures The patients showed deficiency or insufficiency in vitamin A (≤1.05 umol/ L) and vitamin D (≤50 nmol/L) are stratified by gender and randomly assigned in double-blind fashion in a 1:1:1 ...
Eligibility Criteria
Inclusion
- Diagnose of ADHD according to DSM-5
- Aged 6-12 years
- Intelligence quotient (IQ) ≥70
- Receiving methylphenidate (trade name Concerta) 18-54 mg/day once a day (began with 18 mg/day for a week and titrated gradually to the optimum dose not more than 54 mg/day).
Exclusion
- Inconsistent or changing dose of methylphenidate during the participation period
- Use of anticonvulsant drugs or hydrocortisone
- Suffering from other neurological disorders and mental diseases now or in the past, such as convulsions, anxiety and depression
- Suffer from metabolic disorders such as cholestasis, liver dysfunction, pancreatic insufficiency, measles, diarrhea, respiratory illness, severe inflammation or malnutrition, etc.
- Use of vitamins and vitamin-containing products
- IQ≤70
- The serum concentration of vitamin A \>1.05 umol/L and/ or vitamin D \>50 nmol/L
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2022
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT04284059
Start Date
February 25 2021
End Date
August 30 2022
Last Update
April 6 2021
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, China, 400014
2
the First Hospital of Jilin University
Changchun, Jilin, China, 130012
3
Qilu Hospital of Shandong University
Jinan, Shandonng, China, 250012