Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Is oral Vitamin D3 superior to I.M Vitamin D2 in treating vitamin D deficiency?
研究概览
简要总结
The main purpose of this research is to find out if there is any difference between treating vitamin D deficiency with oral vitamin D3 or I.M vitamin D2. The second aim of this research is to confirm the superiority of Vitamin D3 over Vitamin D2 in treating vitamin D deficiency. Additional useful information in this research is to find out the best recommended maintenance dose of vitamin D and formula by having regular follow up of treated individuals once their serum vitamin D level reach the recommended normal serum level.
详细描述
In a systemic review, it was found that treating individuals who have vitamin D deficiency with vitamin D3 rather than vitamin D2 would be a better option. Vitamin D3 is superior in treating Vitamin D deficiency according to this systemic review. However, this systemic review raised a question of comparing oral to I.M treatment of vitamin D deficiency and no Data was available to support either treatment above the other.
The main purpose of this research is to find out if there is any difference between treating vitamin D deficiency with oral vitamin D3 or I.M vitamin D2. The second aim of this research is to confirm the superiority of Vitamin D3 over Vitamin D2 in treating vitamin D deficiency. Additional useful information in this research is to find out the best recommended maintenance dose of vitamin D and formula by having regular follow up of treated individuals once their serum vitamin D level reach the recommended normal serum level.
The research will involve 100 patients between the age of 20-50 years old. They will be divided into 4 groups. Each group will have either oral or I.M vitamin D2 or oral or I.M vitamin D3. The oral doses will be 50000 international units to be taken weekly and the I.M doses will be of 300000 international units which will be taken once every 6 weeks. Vitamin D level will be checked once every 4 weeks. The initial expected duration of the first phase of the research will be about 6-12 weeks which will give us a good orientation to answer the main and the second questions. Then the follow up may take up to another 6 months to check the maintenance dose of the best recommended oral or I.M treatment of bolus doses in certain intervals as initial trial.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-50 years
- •Basal Vit D level should be between 10-18 ng/ml for phase 1 and between 30-50 ng/ml for phase 2
排除标准
- •Pregnant Women
- •history of renal implant or renal impairment of eGFR less than 60%
- •Abnormal Liver function test
- •patients with inflammatory bowel disease or of history of bariatric surgery
研究组 & 干预措施
Group 1: Vitamin D2 50000 units per tablet
They will take one tablet weekly.
干预措施: Vitamin D Deficiency (Drug)
Group 2: Vitamin D2 300000 units Intramuscular injection
They will have one injection every 6 weeks initially.
干预措施: Vitamin D Deficiency (Drug)
Group 3: Vitamin D3 50000 units tablet
They will take one tablet weekly.
干预措施: Vitamin D Deficiency (Drug)
Group 4: Vitamin D3 300000 units Intramuscular injection
They will have one injection every 6 weeks initially.
干预措施: Vitamin D Deficiency (Drug)
结局指标
主要结局
Is oral Vitamin D3 superior to I.M Vitamin D2 in treating vitamin D deficiency?
时间窗: 3 months from the administration of first dose
The primary outcome will be evaluated after 3 months from administration of the first dose for each subject to assess the serum level of vitamin D is attained. If a subject has reached normal Vitamin D serum level, they are qualified for phase 2 of the study.
次要结局
- Confirming superiority of oral Vitamin D3 over oral Vitamin D2(3 months after administration of the first dose.)
- to compare the treatment of vitamin D deficiency by using intramuscular injection of vitamin D3 or Vitamin D2(3 months after administration of the first dose.)
研究者
Dr Hassan Saqr
Senior Consultant
Hamad Medical Corporation