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

University of the Punjab

Status and phase: Completed; Phase 3

Conditions: HIV-1-infection; Hypovitaminosis D

Treatments: Drug: 25-Hydroxyvitamin D; Other: placebo Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05306704

12121218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Control Arm: Olive oil

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo Oil

Vitamin-D

Active Comparator group

Description:

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.

Treatment:

Drug: 25-Hydroxyvitamin D