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Vitamin D Supplementation and TB

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ClinicalTrials.gov Identifier: NCT01992263
Recruitment Status : Not yet recruiting
First Posted : November 25, 2013
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
Arogyavaram Medical Centre
Information provided by (Responsible Party):
Cornell University

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

Condition or disease Intervention/treatment Phase
Tuberculosis Vitamin D Immunity Dietary Supplement: Vitamin D (600 IU) Dietary Supplement: Vitamin D (2000 IU) Dietary Supplement: Vitamin D (4000 IU) Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Trial of Vitamin D Supplementation Among Tuberculosis Patients in South India
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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

Placebo Comparator: Placebo Other: Placebo
Daily oral dose for 12 months




Primary Outcome Measures :
  1. Immune function [ Time Frame: One year ]
    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.

  2. Cell-mediated immunological markers [ Time Frame: One year ]
    T cells

  3. Vitamin D status [ Time Frame: One year ]
    Serum 25(OH)D concentrations


Secondary Outcome Measures :
  1. TB treatment outcomes [ Time Frame: One year ]
    TB treatment success and relapse

  2. HIV disease progression [ Time Frame: One year ]
    WHO HIV disease stages



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992263


Contacts
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Contact: Saurabh Mehta, MBBS, ScD 607-255-2640 smehta@cornell.edu
Contact: Elaine Yu, MPH 714-478-8599 eay27@cornell.edu

Locations
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United States, New York
Cornell University
Ithaca, New York, United States, 14853
Contact: Elaine Yu, MPH    714-478-8599    eay27@cornell.edu   
Principal Investigator: Saurabh Mehta, MBBS, ScD         
India
Arogyavaram Medical Centre (AMC)
Madanapalle, India
Contact: Wesley Bonam, BSc, MBBS, FAIMS, MRSH       wesleywesleyamc@yahoo.co.in   
Sponsors and Collaborators
Cornell University
Arogyavaram Medical Centre
Investigators
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Principal Investigator: Saurabh Mehta, MBBS, ScD Cornell University (U.S.)
Principal Investigator: Wesley Bonam, BSc, MBBS, FAIMS, MRSH Arogyavaram Medical Centre (India)
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01992263    
Other Study ID Numbers: IRB #: 1304003801
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornell University:
tuberculosis
vitamin D
immunity
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents