Clinical trial NCT05306704: High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients Trial
Official title: High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients: A Double-Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1-infection
Hypovitaminosis D
Lead sponsor: University of the Punjab
Sponsor class: OTHER
Collaborators: name: The National HIV/AIDS Programme
First posted: 2022-04-01
Enrollment: 95
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients
timeFrame: Within 12 Weeks
Secondary outcomes:
measure: The secondary outcome is to assess the mean differences in CD4 count
timeFrame: Within 12 Weeks
measure: To measure the effect of our intervention on PCR value copies/µL.
timeFrame: within 12 weeks
measure: To measure the effect of intervention on the viral load value
timeFrame: within 12 weeks
measure: To measure the effect of intervention on SGPT
timeFrame: Within 12 weeks
measure: To measure the effect of intervention on SGOT
timeFrame: Within 12 weeks
measure: To measure the effect of intervention on ALP
timeFrame: Within 12 weeks
measure: To measure the effect of intervention on Bilirubin
timeFrame: Within 12 weeks
Other outcomes:
measure: To access the effect of the intervention on Lymphocytes
timeFrame: within 12 weeks
measure: To access the effect of intervention on Monocytes
timeFrame: within 12 weeks
measure: To access the effect of intervention on Hemoglobin
timeFrame: within 12 weeks
measure: To access the effect of the intervention on Platelets count
timeFrame: Within 12 weeks.
measure: To access the effect of the intervention on Eosionophil
timeFrame: Within 12 weeks
measure: To access the effect of the intervention on Basophil
timeFrame: Within 12 weeks
Locations:
city: Lahore
country: Pakistan
facility: Govt Said Mitha Teaching Hospital Lahore
state: Punjab/ lahore/Pakistan
city: Lahore
country: Pakistan
facility: Fatima Majeed
state: Punjab/ lahore/Pakistan
Study officials:
References: