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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
95
participants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4
Participants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4
Govt Said Mitha Teaching Hospital Lahore
Lahore, Punjab/ lahore/Pakistan, Pakistan
Fatima Majeed
Lahore, Punjab/ lahore/Pakistan, Pakistan
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
Time frame: Within 12 Weeks
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
Time frame: 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
Time frame: 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.
Time frame: within 12 weeks
To measure the effect of intervention on SGPT
The normal value of SGPT is measured in (µL)
Time frame: Within 12 weeks
To measure the effect of intervention on SGOT
The normal value of SGOT is measured in (µL)
Time frame: Within 12 weeks
To measure the effect of intervention on ALP
The normal value of ALP is measured in (µ/l)
Time frame: Within 12 weeks
To measure the effect of intervention on Bilirubin
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The normal value of Bilirubin measured in (mg/dl)
Time frame: Within 12 weeks