Vitamin D Supplementation and TB

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis; Immunity; Vitamin D
• Intervention / Treatment: Dietary supplement: Vitamin D (600 IU); Dietary supplement: Vitamin D (2000 IU); Dietary supplement: Vitamin D (4000 IU); Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saurabh Mehta, MBBS, ScD; Phone Number: 607-255-2640; Email: smehta@cornell.edu
• Study Contact Backup: Name: Elaine Yu, MPH; Phone Number: 714-478-8599; Email: eay27@cornell.edu

Study Locations

• India
  • Madanapalle, India
    • Arogyavaram Medical Centre (AMC)
    • Contact: Wesley Bonam, BSc, MBBS, FAIMS, MRSH; Email: wesleywesleyamc@yahoo.co.in
• United States
  • New York
    • Ithaca, New York, United States, 14853
      • Cornell University
      • Contact: Elaine Yu, MPH; Phone Number: 714-478-8599; Email: eay27@cornell.edu
      • Principal Investigator: Saurabh Mehta, MBBS, ScD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Daily oral dose for 12 months
Experimental: Vitamin D (600 IU)	Dietary supplement: Vitamin D (600 IU); Daily oral dose for 12 months
Experimental: Vitamin D (2000 IU)	Dietary supplement: Vitamin D (2000 IU); Daily oral dose for 12 months
Experimental: Vitamin D (4000 IU)	Dietary supplement: Vitamin D (4000 IU); Daily oral dose for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cell-mediated immunological markers	T cells	One year
Vitamin D status	Serum 25(OH)D concentrations	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TB treatment outcomes	TB treatment success and relapse	One year
HIV disease progression	WHO HIV disease stages	One year

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: Arogyavaram Medical Centre
• Investigators: Principal Investigator: Saurabh Mehta, MBBS, ScD, Cornell University (U.S.); Principal Investigator: Wesley Bonam, BSc, MBBS, FAIMS, MRSH, Arogyavaram Medical Centre (India)

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: vitamin D; tuberculosis; immunity
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: IRB #: 1304003801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No