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

This study has been completed.
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Peter Daley, Christian Medical College
ClinicalTrials.gov Identifier:
NCT00366470
First received: August 18, 2006
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Pulmonary Tuberculosis
 Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml
Other: B. Migliol Oil without Cholecalciferol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Christian Medical College, Vellore, India:

Primary Outcome Measures:
  • Time to sputum culture conversion [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of Patients Culture Positive [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
  • Performance Status [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
  • Time To Sputum Smear Conversion [ Time Frame: Continous ] [ Designated as safety issue: Yes ]
  • Proportion of Patients Smear Positive [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks ] [ Designated as safety issue: Yes ]
  • Time To Growth In Liquid Media [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
  • RNTCP Treatment Outcomes [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Weight Gain [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: B Other: B. Migliol Oil without Cholecalciferol
3.3 ml Migliol Oil, every two weeks for two months

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).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366470

Locations
India
Christian Medical College
Vellore, Tamil Nadu, India, 632004
Bethesda Hospital
Ambur, Tamilnadu, India, 635 802
Sponsors and Collaborators
Peter Daley
Dalhousie University
Investigators
Principal Investigator: Dilip Mathai, MD, FCAMS Christian Medical College, Vellore, India
  More Information

No publications provided

Responsible Party: Peter Daley, Lecturer, Christian Medical College
ClinicalTrials.gov Identifier: NCT00366470     History of Changes
Other Study ID Numbers: TB-VitaminD, CTRI/2007/091/000008
Study First Received: August 18, 2006
Last Updated: July 4, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Cholecalciferol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013