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

NCT05306704 | Completed Phase 3 DMC

• 1 other identifier: 12121218
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV-1-infection; Hypovitaminosis D

Outcome Measures

Primary Outcomes (1)

• 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

  Within 12 Weeks

Secondary Outcomes (7)

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

  Within 12 Weeks

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

  within 12 weeks

• To measure the effect of intervention on the viral load value

  within 12 weeks

• To measure the effect of intervention on SGPT

  Within 12 weeks

• To measure the effect of intervention on SGOT

  Within 12 weeks

Other Outcomes (6)

• To access the effect of the intervention on Lymphocytes

  within 12 weeks

• To access the effect of intervention on Monocytes

  within 12 weeks

• To access the effect of intervention on Hemoglobin

  within 12 weeks

Study Arms (2)

Control Arm: Olive oil

PLACEBO COMPARATOR

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

Vitamin-D

ACTIVE COMPARATOR

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

Interventions

placebo Oil OTHER

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

Also known as: Olive oil

Control Arm: Olive oil

25-Hydroxyvitamin D DRUG

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

Also known as: viatamin-D

Vitamin-D

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant and Lactating Women
• Ability to take Study Medication Orally

Sponsors & Collaborators

• University of the Punjab: lead
• The National HIV/AIDS Programme: collaborator

Study Sites (2)

Govt Said Mitha Teaching Hospital Lahore

Lahore, Punjab/ lahore/Pakistan, 5200, Pakistan

Location

Fatima Majeed

Lahore, Punjab/ lahore/Pakistan, LAHORE, Pakistan

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Olive Oil; 25-hydroxyvitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Its double blind trail so trail is blinded for Participants, Care Provider, Investigator and Outcome Assessor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 1, 2022
• Study Start: February 15, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)