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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:
Peter Daley
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
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:
Further study details as provided by Peter Daley, Christian Medical College:
Primary Outcome Measures:
- Time to sputum culture conversion [ Time Frame: 8 weeks of treatment ]
Secondary Outcome Measures:
- Percent of Patients Culture Positive [ Time Frame: 8 Weeks ]
- Performance Status [ Time Frame: 8 Weeks ]
- Time To Sputum Smear Conversion [ Time Frame: Continous ]
- Proportion of Patients Smear Positive [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks ]
- Time To Growth In Liquid Media [ Time Frame: 8 Weeks ]
- RNTCP Treatment Outcomes [ Time Frame: 24 Weeks ]
- Weight Gain [ Time Frame: 8 Weeks ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00366470
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ( Registry Identifier: Clinical Trials Registry of India ) |
| Study First Received: | August 18, 2006 |
| Last Updated: | July 4, 2012 |
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 |
Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 28, 2017