High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Study is planned in two groups including 1) ARV + Vitamin-D3 2) ARV + Placebo. Methods/design: A randomized placebo controlled double-blind clinical trial of patients with age 19-50 years. The primary outcome will be assessed by analyzing the difference change in the Vitamin-D Levels from Day 1 to Week 12. Secondary outcomes including viral load count, CD4 count, elevated levels of LFTs, will also be assessed by analyzing the mean difference in their values on week 12 after the supplementation of high dose Vitamin-D. Tertiary outcomes (Hematology) including Hb, HCT, TLC, Eosinophil's count, Neutrophils count, Monocytes and Platelets Data will be collected on a predefined Performa. All information will be entered in SPSS for the analysis. Discussion: High dose Vitamin D supplementation in HIV-infected patients has not been previously investigated in Pakistan and it is unknown whether increasing levels is associated with improved clinical outcome or not. Therefore, it is significant to conduct a study to know the effect of vitamin D in the treatment of HIV patients with antiretroviral therapy. Keywords: AIDS, HIV, anti-retroviral therapy, high dose 25-hydroxy Vitamin-D level, CD4 count, viral load.

Official Title
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High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients: A Double-Blind Randomized Control Trial

Conditions
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HIV-1-infection, Hypovitaminosis D

Intervention / Treatment
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* Other: placebo Oil
* Drug: 25-Hydroxyvitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant and Lactating Women Ability to take Study Medication Orally

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group trial design. Parallel arm design is the most commonly used study design. In this design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Arm: Olive oil<br>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. | Other: placebo Oil<br>* participants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4<br>* Other names: Olive oil;|
| Active Comparator: Vitamin-D<br>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. | Drug: 25-Hydroxyvitamin D<br>* Participants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4<br>* Other names: viatamin-D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients | Optimal level of Vitamin-D3 i.e >20ng/ml in HIV patients | Within 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome is to assess the mean differences in CD4 count | Optimal value of CD4 count is 500-1500 cells/mm3 the unit of CD4 count is cells/mm3 | Within 12 Weeks | 
| To measure the effect of our intervention on PCR value copies/µL. | PCR normal value is usually comes under detected and non-detected category and its unit is copies/µL | within 12 weeks | 
| To measure the effect of intervention on the viral load value | The normal value of viral load must be zero and measures in copies/µL of the blood. | within 12 weeks | 
| To measure the effect of intervention on SGPT | The normal value of SGPT is measured in (µL) | Within 12 weeks | 
| To measure the effect of intervention on SGOT | The normal value of SGOT is measured in (µL) | Within 12 weeks | 
| To measure the effect of intervention on ALP | The normal value of ALP is measured in (µ/l) | Within 12 weeks | 
| To measure the effect of intervention on Bilirubin | The normal value of Bilirubin measured in (mg/dl) | Within 12 weeks |