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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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).

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Time to sputum culture conversion [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Daley P, Jagannathan V, John KR, Sarojini J, Latha A, Vieth R, Suzana S, Jeyaseelan L, Christopher DJ, Smieja M, Mathai D. Adjunctive vitamin D for treatment of active tuberculosis in India: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2015 May;15(5):528-34. doi: 10.1016/S1473-3099(15)70053-8. Epub 2015 Apr 8.

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 )
First Posted:	August 21, 2006
Last Update Posted:	July 6, 2012
Last Verified:	July 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