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Completed

NCT Number: NCT00366470

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

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).

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bethesda Hospital, Ambur, Tamil Nadu, India

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

A. 100,000 IU Cholecalciferol per dose of 3.3ml

Drug

100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months

B. Migliol Oil without Cholecalciferol

Other

3.3 ml Migliol Oil, every two weeks for two months

Primary outcomes

  1. Time to sputum culture conversion

    Time frame: 8 weeks of treatment

Secondary outcomes

  1. Percent of Patients Culture Positive

    Time frame: 8 Weeks

  2. Performance Status

    Time frame: 8 Weeks

  3. Time To Sputum Smear Conversion

    Time frame: Continous

  4. Proportion of Patients Smear Positive

    Time frame: 4 Weeks, 8 Weeks, 12 Weeks

  5. Time To Growth In Liquid Media

    Time frame: 8 Weeks

  6. RNTCP Treatment Outcomes

    Time frame: 24 Weeks

  7. Weight Gain

    Time frame: 8 Weeks

Sponsors and collaborators

Lead sponsor

Peter Daley

Other

Collaborators

  • Dalhousie University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 21, 2006
Registry last updated
Jul 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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