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
Bin Peng,
Bin Liu,
Ping Zhou,
Qian Cheng,
Ting Yang,
Li Chen,
Jie Chen,
Yongfang Liu,
Tingyu Li,
Xiaoli Li,
Mark Lee Wolraich,
Ai-hua Cao,
Fei-Yong Jia
Affiliations
Bin Peng
School of Public Health and Management, Department of Health Statistics, Chongqing Medical University, Chongqing, People’s Republic of China
Bin Liu
Medical School of Chinese PLA, Beijing, China
Ping Zhou
3 Emergency Intensive Care Unit, Sichuan Emergency Medical Center, Sichuan Academy of Medical Science, Sichuan Provincial People`s Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
Qian Cheng
Division of Growth, Development and Mental health of Children and Adolescence, Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of China
Ting Yang
Department of Gastroenterology, Changhai Hospital, Naval Medical University, China
Li Chen
11 Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA
Jie Chen
Department of Big Data in Health Science, School of Public Health and The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Yongfang Liu
Division of Clinical Nutrition, Children’s Hospital of Chongqing Medical University, Chongqing, China
Tingyu Li
Division of Growth, Development and Mental health of Children and Adolescence, Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of China
Xiaoli Li
Zhongnan Hospital of Wuhan University, Wuhan, China
Mark Lee Wolraich
Section of Developmental and Behavioral Pediatrics, University of Oklahoma, Oklahoma City, Oklahoma, USA
Ai-hua Cao
Department of Pediatrics, Qilu Hospital of Shandong University, Brain Science Research Institute of Shandong University, Jinan, People’s Republic of China
Fei-Yong Jia
Department of Developmental and Behavioral Pediatrics, The First Hospital of Jilin University, Changchun, People’s Republic of China
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.
