Vitamin D Supplementation and TB

NCT ID: NCT01992263

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2023-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Tuberculosis Vitamin D Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vitamin D (600 IU)

Group Type EXPERIMENTAL

Vitamin D (600 IU)

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose for 12 months

Vitamin D (2000 IU)

Group Type EXPERIMENTAL

Vitamin D (2000 IU)

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose for 12 months

Vitamin D (4000 IU)

Group Type EXPERIMENTAL

Vitamin D (4000 IU)

Intervention Type DIETARY_SUPPLEMENT

Daily oral dose for 12 months

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Daily oral dose for 12 months

Interventions

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Vitamin D (600 IU)

Daily oral dose for 12 months

Intervention Type DIETARY_SUPPLEMENT

Vitamin D (2000 IU)

Daily oral dose for 12 months

Intervention Type DIETARY_SUPPLEMENT

Vitamin D (4000 IU)

Daily oral dose for 12 months

Intervention Type DIETARY_SUPPLEMENT

Placebo

Daily oral dose for 12 months

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arogyavaram Medical Centre

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saurabh Mehta, MBBS, ScD

Role: PRINCIPAL_INVESTIGATOR

Cornell University (U.S.)

Wesley Bonam, BSc, MBBS, FAIMS, MRSH

Role: PRINCIPAL_INVESTIGATOR

Arogyavaram Medical Centre (India)

Locations

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Cornell University

Ithaca, New York, United States

Site Status

Arogyavaram Medical Centre (AMC)

Madanapalle, , India

Site Status

Countries

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United States India

Central Contacts

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Saurabh Mehta, MBBS, ScD

Role: CONTACT

607-255-2640

Elaine Yu, MPH

Role: CONTACT

714-478-8599

Facility Contacts

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Elaine Yu, MPH

Role: primary

714-478-8599

Wesley Bonam, BSc, MBBS, FAIMS, MRSH

Role: primary

Other Identifiers

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IRB #: 1304003801

Identifier Type: -

Identifier Source: org_study_id

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