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

Phase 3

Completed

• Conditions: Hypovitaminosis D; HIV-1-infection
• Interventions: Drug: 25-Hydroxyvitamin D; Other: placebo Oil

• Registration Number: NCT05306704
• Lead Sponsor: University of the Punjab

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-02-15
• Study First Submitted: 2021-04-21
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Study First Submitted QC: 2022-03-31
• Status Verified: 2022-04
• Study First Posted: 2022-04-01
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Age from 19 years and above
2. Vitamin-D levels less than 20ng/ml
3. Not taking any kind of Vitamin-D supplementation or Mega Doses for last six months
4. Written Informed Consent Form
5. PCR Positive Patients

Exclusion Criteria

1. Pregnant and Lactating Women
2. Ability to take Study Medication Orally

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin-D	25-Hydroxyvitamin 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.
Control Arm: Olive oil	placebo 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fatima Majeed; 🇵🇰 Lahore, Punjab/ lahore/Pakistan, Pakistan

Govt Said Mitha Teaching Hospital Lahore; 🇵🇰 Lahore, Punjab/ lahore/Pakistan, Pakistan