Vitamin D Supplementation and TB

Tuberculosis Clinical Trial

Official title:

A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01992263
• Other study ID #: IRB #: 1304003801
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: February 2023

Study information

• Verified date: September 2020
• Source: Cornell University
• Contact: Saurabh Mehta, MBBS, ScD
• Phone: 607-255-2640
• Email: smehta[@]cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to understand the effects of vitamin D supplementation on immunological outcomes among patients with tuberculosis.

Description:

In this randomized trial, the investigators will enroll 200 adults with active pulmonary tuberculosis (TB; among whom 40 have HIV co-infections) at the time of TB diagnosis in S India. The intervention will include daily vitamin D supplementation in 3 treatment arms (600, 2000, and 4000 IU vitamin D), compared to placebo, for 12 months. The investigators' primary objectives are to assess how vitamin D supplementation affects immunity (immunological markers, immune competence) and serum vitamin D levels. Secondary outcomes include TB treatment outcomes (successful sputum smear conversion, relapse) in all patients, and human immunodeficiency virus (HIV) disease progression among a subset of patients with HIV co-infection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Active TB diagnosis by GeneXpert

• HIV infection status (according to AMC HIV clinic medical records of enzyme-linked immunosorbent assay [ELISA] results)

Exclusion Criteria:

• Children (<18 years of age)

• 60 years of age

• Pregnant at baseline

• Other severe complications or illnesses requiring hospitalization

• Received TB treatment for greater than 4 weeks in the past 5 years

• Refused to participate

• Residing in a geographic location > 1 hour from AMC (by public transit)

Related Conditions & MeSH terms

• Immunity
• Tuberculosis
• Vitamin D

Intervention

Dietary Supplement:
• Vitamin D (600 IU)
Daily oral dose for 12 months
• Vitamin D (2000 IU)
Daily oral dose for 12 months
• Vitamin D (4000 IU)
Daily oral dose for 12 months

Other:
• Placebo
Daily oral dose for 12 months

Locations

Country	Name	City	State
India	Arogyavaram Medical Centre (AMC)	Madanapalle
United States	Cornell University	Ithaca	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	Arogyavaram Medical Centre

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune function	Immune responses will be assessed by the superoxide bursts and proteolytic capacities of macrophages and monocytes. Activity indexes will be assessed by comparing mean substrate and calibration fluorescence.	One year
Primary	Cell-mediated immunological markers	T cells	One year
Primary	Vitamin D status	Serum 25(OH)D concentrations	One year
Secondary	TB treatment outcomes	TB treatment success and relapse	One year
Secondary	HIV disease progression	WHO HIV disease stages	One year