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

Sponsor

University of the Punjab (Other)

Overall Status

Completed

CT.gov ID

NCT05306704

Collaborator

The National HIV/AIDS Programme (Other)

Enrollment

Locations

Arms

35.5

Actual Duration (Months)

47.5

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection Hypovitaminosis D	Other: placebo Oil Drug: 25-Hydroxyvitamin D	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Its double blind trail so trail is blinded for Participants, Care Provider, Investigator and Outcome Assessor.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 15, 2019

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Arm: Olive 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.	Other: placebo Oil participants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4 Other Names: Olive oil
Active Comparator: Vitamin-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.	Drug: 25-Hydroxyvitamin D Participants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4 Other Names: viatamin-D

Arm

Intervention/Treatment

Placebo Comparator: Control Arm: Olive 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.

Other: placebo Oil

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

Other Names:

Olive oil

Active Comparator: Vitamin-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.

Drug: 25-Hydroxyvitamin D

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

Other Names:

viatamin-D

Outcome Measures

Primary Outcome Measures

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

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 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 SGPT [Within 12 weeks]
The normal value of SGPT is measured in (µL)
To measure the effect of intervention on SGOT [Within 12 weeks]
The normal value of SGOT is measured in (µL)
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 intervention on Bilirubin [Within 12 weeks]
The normal value of Bilirubin measured in (mg/dl)

Other Outcome Measures

To access the effect of the intervention on Lymphocytes [within 12 weeks]
The units for Lymphocytes is in percentage %
To access the effect of intervention on Monocytes [within 12 weeks]
The units for Monocytes is in percentage %
To access the effect of intervention on Hemoglobin [within 12 weeks]
The hemoglobin level is measured in g/dl
To access the effect of the intervention on Platelets count [Within 12 weeks.]
The platelets count is normally measured in 1000/µL
To access the effect of the intervention on Eosionophil [Within 12 weeks]
The platelets count is normally measured in percentage %
To access the effect of the intervention on Basophil [Within 12 weeks]
The Basophil count is normally measured in percentage %

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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