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. 2021 Jun 16;11(6):e050541.
doi: 10.1136/bmjopen-2021-050541.

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

Ping Zhou  1   2 , Mark Lee Wolraich  3 , Ai-Hua Cao  4 , Fei-Yong Jia  5 , Bin Liu  6 , Lin Zhu  1   2 , Yongfang Liu  7 , Xiaoli Li  1   2 , Chao Li  8 , Bin Peng  9 , Ting Yang  2 , Jie Chen  2 , Qian Cheng  1   2 , Tingyu Li  1   2 , Li Chen  10   2
Affiliations

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

Ping Zhou et al. BMJ Open. .

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.

Keywords: neurobiology; paediatrics; protocols & guidelines; public health.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow diagram of the study protocol. ADHD, attention-deficit/hyperactivity disorder; QCD, Questionnaire–Children with Difficulties.
See this image and copyright information in PMC

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