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Around 7.2% of children around the world are suffering from ADHD. On account of current medical treatment, a high remission rate can be reached for ADHD. Nevertheless, patients have to face a number of side effects associated with the treatment. It was informed that patients of ADHD have a tendency to vitamin A and vitamin D deficiency. The aim of the study is to determine the effect of vitamin A and vitamin D supplementation as adjunctive therapy to methylphenidate on symptoms of ADHD. 504 subjects aged 6-12 years with a diagnosis of ADHD based on DSM-5 criteria are randomly assigned into three groups to receive vitamin A 6000 IU/day and vitamin D 2100 IU/day, or vitamin D 2100 IU/day or placebo adding to methylphenidate for 8 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales and Questionnaire - Children with Difficulties at weeks 0, 4, and 8. Serum levels of retinol and 25(OH)D are measured at baseline and after 8 weeks. All the other sociodemographic data are assessed. The study can give more references on the application of vitamin A and vitamin D in addition to methylphenidate to ADHD. Future research is needed to clarify mechanism of vitamin A and vitamin D on ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin AD group | Active Comparator | 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. |
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| vitamin D group | Experimental | 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. |
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| placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebos | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent assessment scale | The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome. | at baseline |
| The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher assessment scale | The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Inattentive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 1-9 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome. | at baseline |
| The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent assessment scale | The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of vitamin A. | Vitamin A state is measured by the serum concentration of retinol through high performance liquid chromatography (HPLC) from 2 milliliter of venous blood. The vitamin A status is categorized based on serum retinol: <0.35 µmol/L is considered very deficient, 0.35-0.7 µmol/L deficient, 0.7-1.05 µmol/L marginal, 1.05-2.56 µmol/L adequate, and >2.56 µmol/L toxic. Too low or too high concentrations are harmful |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Chen, doctor | Contact | 136 7762 0103 | +86 | chenli2012@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Chen, doctor | Children's Hospital of Chongqing Medical University | Study Director |
| yu T Li, MS | Children's Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Growth, Development and Mental health of Children and Adolescence Center | Recruiting | Chongqing | Chongqing Municipality | 400014 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30456564 | Background | Dehbokri N, Noorazar G, Ghaffari A, Mehdizadeh G, Sarbakhsh P, Ghaffary S. Effect of vitamin D treatment in children with attention-deficit hyperactivity disorder. World J Pediatr. 2019 Feb;15(1):78-84. doi: 10.1007/s12519-018-0209-8. Epub 2018 Nov 19. | |
| 29457493 | Background | Elshorbagy HH, Barseem NF, Abdelghani WE, Suliman HAI, Al-Shokary AH, Abdulsamea SE, Elsadek AE, Abdel Maksoud YH, Nour El Din DMAE. Impact of Vitamin D Supplementation on Attention-Deficit Hyperactivity Disorder in Children. Ann Pharmacother. 2018 Jul;52(7):623-631. doi: 10.1177/1060028018759471. Epub 2018 Feb 18. |
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Data is confidential during the study.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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The patients showed deficiency or insufficiency in vitamin A (≤1.05 umol/ L) and vitamin D (≤50 nmol/L) are randomly assigned in double-blind fashion in a 1:1:1 ratio to the vitamin AD supplementation group, vitamin D supplementation group or the placebo group. Vitamin AD supplementation group will be administrated vitamin AD capsules (3 capsules/time, once a day for 8 weeks), which contain vitamin A (2000 IU/capsule) and vitamin D (700 IU/capsule). Vitamin D supplementation group will be administrated vitamin D capsules (400 IU/capsule, 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks). The placebo capsules given to the placebo group (3 capsules/time, once a day for 8 weeks), consists of oily liquids which do not contain vitamin A and vitamin D, and were produced in strict accordance with China's drug management and packaging requirements for placebo by Shandong DYNE Marine Biopharmaceutical Co., Ltd in China.
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The participants and care providers don't know which group they are enrolled in. And the investigators just play a roll in recruiting the patients, inform the patients about the study, and then randomly assign the patients in a 1:1:1 ratio to the A group, B group or C group. The drugs are dispensed by staff who was not involved in the process of evaluation, diagnosis and treatment. The staff will take notes about the patients' basic information and medication records. After the study, the staff will give the unblinded results to to investigators and outcomes assessor. The investigators will provide the compensatory therapy for the patients. The outcomes assessor will do the statistic analysis.
| vitamin AD | Dietary Supplement | 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. |
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| vitamin D | Dietary Supplement | 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. |
|
| at baseline |
| The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher assessment scale | The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for Predominantly Hyperactive/Impulsive subtype: Must score a 2 or 3 on 6 out of 9 items on questions 10-18 AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome. | at baseline |
| The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent assessment scale | The Vanderbilt parent assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 49-56. The higher scores mean a worse outcome. | at baseline |
| The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher assessment scale | The Vanderbilt teacher assessment scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard for ADHD Combined Inattention/Hyperactivity: Must score a 2 or 3 on 6 out of 9 items not only on questions 1-9 but also on questions 10-18. AND Score a 4 or 5 on any of the Performance questions 36-43. The higher scores mean a worse outcome. | at baseline |
| The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment | The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome. | at weeks 4 and 8 |
| The changes in ADHD clinical symptoms-Predominantly Inattentive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment | The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Inattentive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome. | at weeks 4 and 8 |
| The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt parent follow-up assessment | The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome. | at weeks 4 and 8 |
| The changes in ADHD clinical symptoms-Predominantly Hyperactive/Impulsive subtype estimated by Chinese version of Vanderbilt teacher follow-up assessment | The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for Predominantly Hyperactive/Impulsive subtype: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome. | at weeks 4 and 8 |
| The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt parent follow-up assessment | The Vanderbilt parent follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome. | at weeks 4 and 8 |
| The changes in ADHD clinical symptoms-ADHD Combined Inattention/Hyperactivity estimated by Chinese version of Vanderbilt teacher follow-up assessment | The Vanderbilt teacher follow-up assessment is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard for ADHD Combined Inattention/Hyperactivity: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome. | at weeks 4 and 8 |
| The changes in ADHD clinical symptoms | The Questionnaire - Children with Difficulties (QCD) measures the daily-life problems in children aged 6-18 years during the special time of the day, including in the morning, during school, after school, in the evening, and overall difficulties over the entire day and night. It has been proved the Chinese version of QCD has good validity and reliability. Filled in by the parents, the scale consists of 20 questions with regard to ADHD-related difficulties. Each question is scored on a four-point scale: 0 = completely disagree, 1 = somewhat (partially) agree, 2 = mostly agree, and 3 = completely agree. Score of 30 - 35 is considered as cut-off value for functional impairment and score of less than 30 is considered as functional impairment (Full marks: 57). The lower scores indicate lower life functioning and more difficulty in children's daily activities. | at baseline, weeks 4 and 8 |
| at baseline and weeks 8 |
| Serum concentration of vitamin D. | Vitamin D state is measured by the serum concentration of 25OHD through high performance liquid chromatography (HPLC) from 2 milliliter of venous blood. The values of serum vitamin D level are classified into 4 categories: <30 nmol/L is regarded as deficiency, 30-50 nmol/L insufficiency, 50-250 nmol/L normal, and >250 nmol/L toxic . Too low or too high concentrations are harmful。 | at baseline and weeks 8 |
| the First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130012 | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandonng | 250012 | China |
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