High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients: A Double-Blind Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients
研究概览
简要总结
High-Dose Vitamin D3 in the Treatment of Human Immune Deficiency Virus Patients, A Double-Blind Randomized Control Trial Human immunodeficiency virus is a key challenge for global health. Vitamin D deficiency is common in people living with HIV infection. Antiretroviral therapy may create unique risk factors for vitamin D insufficiency, including alterations of vitamin D metabolism by ART.
详细描述
The study is designed to evaluate the effect of high dose Vitamin-D supplementation in the treatment of HIV patients with Antiretroviral therapy.
Furthermore, in secondary outcomes study will evaluate the effects of high dose vitamin-D supplementation by Pre & Post assessments of CD4 count and PCR count.
Secondary outcomes also includes the effects of high dose vitamin-D supplementation by Pre & Post assessments of SGPT, SGOT, ALP and Bilirubin.
Tertiary outcomes includes the effects of high dose vitamin-D supplementation by Pre & Post assessments of Hb, Lymphocytes, Monocytes, Eosinophil, Platelet count and Basophil count.
A sample size of 95 patients were recruited in Said Mitha Teaching Hospital Lahore.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Its double blind trail so trail is blinded for Participants, Care Provider, Investigator and Outcome Assessor.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 19 years and above
- •Vitamin-D levels less than 20ng/ml
- •Not taking any kind of Vitamin-D supplementation or Mega Doses for last six months
- •Written Informed Consent Form
- •PCR Positive Patients
排除标准
- •Pregnant and Lactating Women
- •Ability to take Study Medication Orally
研究组 & 干预措施
Control Arm: Olive oil
In control arm participants will receive Placebo (Olive Oil) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list.
干预措施: placebo Oil (Other)
Vitamin-D
In the Vitamin-D arm, participants will receive Vitamin-D (100000 IU) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list.
干预措施: 25-Hydroxyvitamin D (Drug)
结局指标
主要结局
Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients
时间窗: Within 12 Weeks
Optimal level of Vitamin-D3 i.e \>20ng/ml in HIV patients
次要结局
- To measure the effect of intervention on SGPT(Within 12 weeks)
- The secondary outcome is to assess the mean differences in CD4 count(Within 12 Weeks)
- To measure the effect of intervention on ALP(Within 12 weeks)
- To measure the effect of our intervention on PCR value copies/µL.(within 12 weeks)
- To measure the effect of intervention on the viral load value(within 12 weeks)
- To measure the effect of intervention on Bilirubin(Within 12 weeks)
- To measure the effect of intervention on SGOT(Within 12 weeks)
研究者
Fatima Majeed
principal investigator
Services Hospital, Lahore