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NCT Number: NCT05306704

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

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.

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Key information

Conditions

HIV-1-infection Avitaminosis Deficiency Diseases Hypovitaminosis D Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fatima Majeed, Lahore, Punjab/ lahore/Pakistan, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo oil

Other

participants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4

Other names: Olive oil

25-Hydroxyvitamin D

Drug

Participants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4

Other names: viatamin-D

Primary outcomes

  1. Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients

    Time frame: Within 12 Weeks

    Optimal level of Vitamin-D3 i.e >20ng/ml in HIV patients

Secondary outcomes

  1. The secondary outcome is to assess the mean differences in CD4 count

    Time frame: Within 12 Weeks

    Optimal value of CD4 count is 500-1500 cells/mm3 the unit of CD4 count is cells/mm3

  2. To measure the effect of our intervention on PCR value copies/µL.

    Time frame: within 12 weeks

    PCR normal value is usually comes under detected and non-detected category and its unit is copies/µL

  3. To measure the effect of intervention on the viral load value

    Time frame: within 12 weeks

    The normal value of viral load must be zero and measures in copies/µL of the blood.

  4. To measure the effect of intervention on SGPT

    Time frame: Within 12 weeks

    The normal value of SGPT is measured in (µL)

  5. To measure the effect of intervention on SGOT

    Time frame: Within 12 weeks

    The normal value of SGOT is measured in (µL)

  6. To measure the effect of intervention on ALP

    Time frame: Within 12 weeks

    The normal value of ALP is measured in (µ/l)

  7. To measure the effect of intervention on Bilirubin

    Time frame: Within 12 weeks

    The normal value of Bilirubin measured in (mg/dl)

Other outcomes

  1. To access the effect of the intervention on Lymphocytes

    Time frame: within 12 weeks

    The units for Lymphocytes is in percentage %

  2. To access the effect of intervention on Monocytes

    Time frame: within 12 weeks

    The units for Monocytes is in percentage %

  3. To access the effect of intervention on Hemoglobin

    Time frame: within 12 weeks

    The hemoglobin level is measured in g/dl

  4. To access the effect of the intervention on Platelets count

    Time frame: Within 12 weeks.

    The platelets count is normally measured in 1000/µL

  5. To access the effect of the intervention on Eosionophil

    Time frame: Within 12 weeks

    The platelets count is normally measured in percentage %

  6. To access the effect of the intervention on Basophil

    Time frame: Within 12 weeks

    The Basophil count is normally measured in percentage %

Sponsors and collaborators

Lead sponsor

University of the Punjab

Other

Collaborators

  • The National HIV/AIDS Programme

Registry information

Official study title

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

Acronym: HDVDS-HIVT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2022
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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