A Pilot Study Evaluating the Effect of Vitamin D on Clinical Outcome in Autistic Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
研究概览
简要总结
The purpose of this study to determine whether high dose vitamin D has positive effect on behavior of autistic children.
详细描述
Double blinded placebo controlled study to determine effect of two different doses of vitamin D on Behavioral domains in autistic children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfill fourth edition of Diagnostic and statistical manual of mental Disorders (DSM 4th) criteria for autism
排除标准
- •Patients who had seizures within the past year or History of kidney or liver disease or Taking the following medications or supplements that may affect vitamin D level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. None of the study participants received vitamin D or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.
研究组 & 干预措施
Vitamin D group
Patients will receive vitamin D drug with generic name: V drops manufactured by Medical Union Pharmaceuticals, Egypt Dosage form: liquid drops Dosage, frequency, and Duration:1000 international units per day for 3 months then 1000 international units per 25 pounds per day for another 3 months.
干预措施: Vitamin D3 (Drug)
Placebo group
Patients will receive glucose syrup same taste and color as vitamin D3 drops with same dosage regimen to vitamin D group.
干预措施: Placebo (Other)
结局指标
主要结局
Effect of vitamin D on changes in behavioral measures (Childhood autism rating scale)
时间窗: At baseline, 12 weeks ,24 weeks
Effect of vitamin D on changes in behavioral measures (autism treatment evaluation checklist)
时间窗: At baseline, 12 weeks ,24 weeks
次要结局
- Effect of vitamin D on calcium level(At baseline, 12 weeks ,24 weeks)
- Effect of vitamin D on phosphorous level(At baseline, 12 weeks ,24 weeks)
- Effect of vitamin D on alkaline phosphatase level(At baseline,12 weeks ,24 weeks)
- Effect of vitamin D on parathyroid hormone level(At baseline,12 weeks ,24 weeks)
- Effect of vitamin D on liver function test (alanine transaminase and aspartate transaminase)(At baseline, 12 weeks ,24 weeks)
- Effect of vitamin D on kidney function test (Blood urea nitrogen and serum creatinine)(At baseline, 12 weeks ,24 weeks)
研究者
Sarah Farid Mohamed Fahmy
Assistant lecturer in clinical pharmacy
Ain Shams University