Adjuvant Effects of Vitamin A and Vitamin D Supplementation on Treatment of Children With ADHD
NCT ID: NCT04284059
Last Updated: 2021-04-06
Study Results
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Basic Information
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UNKNOWN
PHASE4
504 participants
INTERVENTIONAL
2021-02-25
2022-08-30
Brief Summary
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Detailed Description
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2. Demographic questionnaire and clinical data The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, blood pressure, heart rate ; supplementation of vitamin A/D products or vitamin A/D-containing products. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis, disease classification, current treatment, and comorbid conditions.
3. Sample size This study is a randomized double-blind controlled trial. Intervention groups are vitamin AD group and vitamin D group, control group is placebo group. The primary outcome index is changes in ADHD symptoms evaluated by Vanderbilt Assessment Scales and Questionnaire - Children with Difficulties (QCD) in the last 4 weeks or 8 weeks. The second outcome is the serum concentration of vitamin A and vitamin D. Conner's Parent Rating Scale (CPRS) was considered as the main outcome in the previous literature, the mean ± SD of ADHD index was 55.84 ± 10.2, 56.79 ± 9.6 for vitamin D + methylphenidate(n = 25), placebo + methylphenidate (n = 29) respectively. The investigators cautiously presume that the mean ± SD for vitamin AD + methylphenidate is 54 ± 9.88. Considering 0.05 of the alpha and 0.80 of power, a sample of 453 subjects divided among 3 groups are calculated by PASS 2020. And 504 subjects are enrolled in the study based on the dropout rate of 10%.
4. Statistical analysis All the data are analyzed using SPSS 19.0. The normality of variables are assessed by Kolmogorov Smirnov test. Comparison of parametric and nonparametric variables between groups are examined by F test and Kruskal-Wallis test, respectively. Paired t-test and Wilcoxon signed-rank test are used to investigate within-group differences. Confounding factors are adjusted by the analysis of covariance.
5. Bias control the investigators will describe both responders and non-responders on demographic questionnaire and clinical data in detail to assess the selection bias. And in order to decrease the dropout rate, the investigators will contact with the patient's parents about compliance to therapy by Wechat, E-mail, sometimes telephone contact is necessary.
6. Ethical matters and data protection The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee . Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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vitamin AD group
The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin A 6000 IU/day and vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks.
vitamin AD
A vitamin AD capsule contains vitamin A 2000 IU and vitamin D 700 IU. The patients need to administrate 3 capsules once a day for 8 weeks.
vitamin D group
The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive vitamin D 2100 IU/day supplementation in addition to methylphenidate for 8 weeks. After the study, vitamin D group will be administrated with vitamin A on the basis of serum retinol concentration after the study.
vitamin D
A vitamin D capsule contains vitamin D 400 IU. The patients need to asministrate 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks.
placebo group
The patients aged 6-12 with a diagnose of ADHD of this group is deficient or insufficient in vitamin A and vitamin D. They will receive placebo once a day in addition to methylphenidate for 8 weeks. After the study, the placebo group will be prescribed with vitamin A and vitamin D supplementation on the grounds of retinol and 25 (OH)D concentration.
Placebos
Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. The patients need to administrate 3 capsules once a day for 8 weeks.
Interventions
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Placebos
Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. The patients need to administrate 3 capsules once a day for 8 weeks.
vitamin AD
A vitamin AD capsule contains vitamin A 2000 IU and vitamin D 700 IU. The patients need to administrate 3 capsules once a day for 8 weeks.
vitamin D
A vitamin D capsule contains vitamin D 400 IU. The patients need to asministrate 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
12 Years
ALL
No
Sponsors
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Chen Li
OTHER
Responsible Party
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Chen Li
Associate Professor，Director
Principal Investigators
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Li Chen, doctor
Role: STUDY_DIRECTOR
Children's Hospital of Chongqing Medical University
yu T Li, MS
Role: STUDY_CHAIR
Children's Hospital of Chongqing Medical University
Locations
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Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, China
the First Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandonng, China
Countries
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Central Contacts
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Facility Contacts
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References
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Zhou P, Wolraich ML, Cao AH, Jia FY, Liu B, Zhu L, Liu Y, Li X, Li C, Peng B, Yang T, Chen J, Cheng Q, Li T, Chen L. 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. 2021 Jun 16;11(6):e050541. doi: 10.1136/bmjopen-2021-050541.
Other Identifiers
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CHENLI
Identifier Type: -
Identifier Source: org_study_id
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