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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

Authors :
Bin Peng
Bin Liu
Ping Zhou
Chao Li
Qian Cheng
Ting Yang
Jie Chen
Lin Zhu
Yongfang Liu
Tingyu Li
Xiaoli Li
Mark Lee Wolraich
Ai-hua Cao
Fei-Yong Jia
Source :
BMJ Open, Vol 11, Iss 6 (2021)
Publication Year :
2021
Publisher :
BMJ Publishing Group, 2021.

Abstract

Introduction Approximately 7.2% of children in the world suffer from attention-deficit/hyperactivity disorder (ADHD). Due to the availability of the osmotic-release oral-system methylphenidate, ADHD currently has a remission rate of up to 30.72%. Nevertheless, it has been reported that patients with ADHD tend to exhibit vitamin A and vitamin D deficiency, which may aggravate the symptoms of ADHD. This study aims to determine the effect of vitamin A and vitamin D supplementation as adjunctive therapy to methylphenidate on the symptoms of ADHD.Methods and analysis This is a parallel, prospective, interventional multicentric study. Patients will be enrolled from the southern, central and northern parts of China. A target of 504 patients will be followed for 8 weeks. They will be allocated into three groups (vitamin AD, vitamin D and placebo) and administered the interventions accordingly. Data on changes in the symptoms of ADHD as well as changes in the serum concentrations of vitamin A and vitamin D will be recorded. Both responders and nonresponders based on the sociodemographic and clinical data will also be described to mitigate selection bias.Ethics and dissemination This study is performed in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Children’s Hospital of Chongqing Medical University, China (approval number: (2019) IRB (STUDY) number 262). The results of the trial will be reported in peer-reviewed scientific journals and academic conferences regardless of the outcomes.Trial registration number NCT04284059.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
11
Issue :
6
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.14a4c5beffa4e2dba17f78f0c8f9223
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2021-050541