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 |
Recruitment Status :
Completed
First Posted : August 21, 2006
Last Update Posted : July 6, 2012
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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 |
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 |

Arm | Intervention/treatment |
---|---|
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 |
- Time to sputum culture conversion [ Time Frame: 8 weeks of treatment ]
- 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 |
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

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
India | |
Christian Medical College | |
Vellore, Tamil Nadu, India, 632004 | |
Bethesda Hospital | |
Ambur, Tamilnadu, India, 635 802 |
Principal Investigator: | Dilip Mathai, MD, FCAMS | Christian Medical College, Vellore, India |
Responsible Party: | Peter Daley, Lecturer, Christian Medical College, Vellore, India |
ClinicalTrials.gov Identifier: | NCT00366470 |
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 |
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Cholecalciferol Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents |