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
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...
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BMJ Publishing Group
2021-06-01
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| author | 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 |
| author_facet | 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 |
| author_sort | Bin Peng |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a14a4c5beffa4e2dba17f78f0c8f9223 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a14a4c5beffa4e2dba17f78f0c8f92232024-11-18T20:25:11ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2021-050541Adjuvant 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 ChinaBin Peng0Bin Liu1Ping Zhou2Qian Cheng3Ting Yang4Li Chen5Jie Chen6Yongfang Liu7Tingyu Li8Xiaoli Li9Mark Lee Wolraich10Ai-hua Cao11Fei-Yong Jia12School of Public Health and Management, Department of Health Statistics, Chongqing Medical University, Chongqing, People’s Republic of ChinaMedical School of Chinese PLA, Beijing, China3 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, ChinaDivision of Growth, Development and Mental health of Children and Adolescence, Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of ChinaDepartment of Gastroenterology, Changhai Hospital, Naval Medical University, China11 Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USADepartment of Big Data in Health Science, School of Public Health and The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, ChinaDivision of Clinical Nutrition, Children’s Hospital of Chongqing Medical University, Chongqing, ChinaDivision of Growth, Development and Mental health of Children and Adolescence, Children’s Hospital of Chongqing Medical University, Chongqing, People’s Republic of ChinaZhongnan Hospital of Wuhan University, Wuhan, ChinaSection of Developmental and Behavioral Pediatrics, University of Oklahoma, Oklahoma City, Oklahoma, USADepartment of Pediatrics, Qilu Hospital of Shandong University, Brain Science Research Institute of Shandong University, Jinan, People’s Republic of ChinaDepartment of Developmental and Behavioral Pediatrics, The First Hospital of Jilin University, Changchun, People’s Republic of ChinaIntroduction 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.https://bmjopen.bmj.com/content/11/6/e050541.full |
| spellingShingle | 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 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/11/6/e050541.full |
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