A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
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| ClinicalTrials.gov Identifier: NCT00366470 |
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Recruitment Status :
Completed
First Posted : August 21, 2006
Last Update Posted : July 6, 2012
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Sponsor:
Peter Daley
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Peter Daley, Christian Medical College, Vellore, India
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Tuberculosis | Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml Other: B. Migliol Oil without Cholecalciferol | Phase 3 |
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 (Clinical Trial) |
| Actual Enrollment : | 250 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (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 |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
Vitamin D in doses of 100,000 IU
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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 |
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 ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| 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
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): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Peter Daley, Lecturer, Christian Medical College, Vellore, India |
| ClinicalTrials.gov Identifier: | NCT00366470 History of Changes |
| Other Study ID Numbers: |
TB-VitaminD CTRI/2007/091/000008 ( Registry Identifier: Clinical Trials Registry of India ) |
| First Posted: | August 21, 2006 Key Record Dates |
| Last Update Posted: | July 6, 2012 |
| Last Verified: | July 2012 |
Additional relevant MeSH terms:
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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 |