A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients

July 4, 2012 updated by: Peter Daley

A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy

There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in TB patients treated with vitamin D in combination with standard DOTS therapy. It will take place in four South Indian DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a 1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College
    • Tamilnadu
      • Ambur, Tamilnadu, India, 635 802
        • Bethesda Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Newly diagnosed smear positive pulmonary tuberculosis.
  2. Age between 18 to 75 years
  3. No pre-existing liver or renal disease
  4. Available for return visits as outlined in the trial protocol
  5. A Firm home address

Exclusion Criteria:

  1. Extra-pulmonary or smear negative tuberculosis
  2. Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
  3. Pregnant or lactating women
  4. Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
  5. Baseline Hypercalcemia >10.5 mg/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Other: B. Migliol Oil without Cholecalciferol
3.3 ml Migliol Oil, every two weeks for two months
Experimental: A
Vitamin D in doses of 100,000 IU
Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml
100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to sputum culture conversion
Time Frame: 8 weeks of treatment
8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of Patients Culture Positive
Time Frame: 8 Weeks
8 Weeks
Performance Status
Time Frame: 8 Weeks
8 Weeks
Time To Sputum Smear Conversion
Time Frame: Continous
Continous
Proportion of Patients Smear Positive
Time Frame: 4 Weeks, 8 Weeks, 12 Weeks
4 Weeks, 8 Weeks, 12 Weeks
Time To Growth In Liquid Media
Time Frame: 8 Weeks
8 Weeks
RNTCP Treatment Outcomes
Time Frame: 24 Weeks
24 Weeks
Weight Gain
Time Frame: 8 Weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Daley

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Dilip Mathai, MD, FCAMS, Christian Medical College, Vellore, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

August 18, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Estimate)

July 6, 2012

Last Update Submitted That Met QC Criteria

July 4, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB-VitaminD
  • CTRI/2007/091/000008 (Registry Identifier: Clinical Trials Registry of India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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