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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

Primary Purpose

Pulmonary Tuberculosis

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

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

B. Migliol Oil without Cholecalciferol

About this trial

This is an interventional treatment trial for Pulmonary Tuberculosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Christian Medical College
Bethesda Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Vitamin D in doses of 100,000 IU

Outcomes

Primary Outcome Measures

Time to sputum culture conversion

Secondary Outcome Measures

Percent of Patients Culture Positive

Performance Status

Time To Sputum Smear Conversion

Proportion of Patients Smear Positive

Time To Growth In Liquid Media

RNTCP Treatment Outcomes

Weight Gain

Full Information

NCT ID

NCT00366470

First Posted

August 18, 2006

Last Updated

July 4, 2012

Sponsor

Peter Daley

Collaborators

Dalhousie University

1. Study Identification

Unique Protocol Identification Number

NCT00366470

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Peter Daley

Collaborators

Dalhousie University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Tuberculosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Vitamin D in doses of 100,000 IU

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

B. Migliol Oil without Cholecalciferol

Intervention Description

3.3 ml Migliol Oil, every two weeks for two months

Primary Outcome Measure Information:

Title

Time to sputum culture conversion

Time Frame

8 weeks of treatment

Secondary Outcome Measure Information:

Title

Percent of Patients Culture Positive

Time Frame

8 Weeks

Title

Performance Status

Time Frame

8 Weeks

Title

Time To Sputum Smear Conversion

Time Frame

Continous

Title

Proportion of Patients Smear Positive

Time Frame

4 Weeks, 8 Weeks, 12 Weeks

Title

Time To Growth In Liquid Media

Time Frame

8 Weeks

Title

RNTCP Treatment Outcomes

Time Frame

24 Weeks

Title

Weight Gain

Time Frame

8 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dilip Mathai, MD, FCAMS

Organizational Affiliation

Christian Medical College, Vellore, India

Official's Role

Principal Investigator

Facility Information:

Facility Name

Christian Medical College

City

Vellore

State/Province

Tamil Nadu

ZIP/Postal Code

632004

Country

India

Facility Name

Bethesda Hospital

City

Ambur

State/Province

Tamilnadu

ZIP/Postal Code

635 802

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

25863562

Citation

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.

Results Reference

derived

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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

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