Changes in Serum Vitamin D Level and Clinical Parameters After Different Loading Doses of Cholecalciferol (D3) in Young Adults With Vitamin D Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 主要终点
- serum 25(OH)D
研究概览
简要总结
it is a clinical trial to observe increase in serum vitamin D level and clinical symptoms after 3 different doses of cholecalciferol given either intramuscularly or oral.
详细描述
A prospective, interventional study was conducted in Department of Rheumatology, BSMMU, Dhaka, Bangladesh from October 2015 to January 2017. One hundred and five clinically healthy adults of age 21-39 with serum vitamin D concentration were enrolled in the study. Serum vitamin D level was estimated by chemiluminescent micro particle immunoassay method at baseline and 3 months after the intervention. The participants were divided into three groups using random number table. Group A was given 6 lakh IU of cholecalciferol IM stat dose, group B was given 6 lakh IU of cholecalciferol orally with a glass of milk stat dose and group c was given 2 lakh IU of cholecalciferol orally once a month for 2 months followed by tablet cholecalciferol 1000 IU daily.
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
- None
入排标准
- 年龄范围
- 21 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •hypovitaminosis D (serum 25 OH D < 20 ng/ml)
排除标准
- •Chronic disease causing Vitamin D deficiency like CKD, nephrotic syndrome, liver disease, hyperparathyroidism, history of skin graft, malabsorption, hyperthyroidism, drugs like anticonvulsants, glucocorticoids, HAART Current pregnancy Lactose intolerance Previously treated with bolus Vitamin D supplementation within previous three months
研究组 & 干预措施
high dose IM
cholecalciferol 600,000 IU given intramuscularly
干预措施: Cholecalciferol (Drug)
high dose oral
cholecalciferol 600,000 IU given orally
干预措施: Cholecalciferol (Drug)
low dose oral
cholecalciferol 400,000 IU given orally in 2 divided doses given monthly for 2 consecutive months followed by daily maintenance dose of 1000 IU
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
serum 25(OH)D
时间窗: 3 months
serum vitamin D level in ng/ml measured by CLIA method
次要结局
- fatigue(3 months)
- generalized weakness(3 months)
- bone pain(3 months)
- muscle cramps(3 months)
- pain in weight bearing joints(3 months)
- difficulty in climbing stairs(3 months)
- difficulty in standing from squatting position(3 months)
研究者
Dr Shweta Nakarmi
Principle Investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh