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

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chen Li
• Treatments: Ergocalciferols; Methylphenidate; Retinol palmitate; Vitamin A; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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