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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

NCT ID: NCT00366470

Last Updated: 2012-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-05-31

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Pulmonary Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Vitamin D in doses of 100,000 IU

Group Type EXPERIMENTAL

A. 100,000 IU Cholecalciferol per dose of 3.3ml

Intervention Type DRUG

100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months

B

Group Type PLACEBO_COMPARATOR

B. Migliol Oil without Cholecalciferol

Intervention Type OTHER

3.3 ml Migliol Oil, every two weeks for two months

Interventions

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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

Intervention Type DRUG

B. Migliol Oil without Cholecalciferol

3.3 ml Migliol Oil, every two weeks for two months

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalhousie University

OTHER

Sponsor Role collaborator

Peter Daley

OTHER

Sponsor Role lead

Responsible Party

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Peter Daley

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dilip Mathai, MD, FCAMS

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College, Vellore, India

Locations

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Bethesda Hospital

Ambur, Tamil Nadu, India

Site Status

Christian Medical College

Vellore, Tamil Nadu, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 25863562 (View on PubMed)

Related Links

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http://www.tbcindia.org/pdfs/TB%20India-2005%20Page%201-54.pdf

TB control in India

Other Identifiers

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CTRI/2007/091/000008

Identifier Type: REGISTRY

Identifier Source: secondary_id

TB-VitaminD

Identifier Type: -

Identifier Source: org_study_id