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

Sponsors and Collaborators:	Christian Medical College, Vellore, India Dalhousie University
Information provided by:	Christian Medical College, Vellore, India
ClinicalTrials.gov Identifier:	NCT00366470

Purpose

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	Intervention	Phase
Pulmonary Tuberculosis	Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml Other: B. Migliol Oil without Cholecalciferol	Phase III

MedlinePlus related topics: Tuberculosis

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 on Sputum Culture Conversion

Further study details as provided by Christian Medical College, Vellore, India:

Primary Outcome Measures:

percent culture conversion [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures:

Proportion 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 ]

Estimated Enrollment:	450
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
A: Experimental	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
B: Placebo Comparator	Other: B. Migliol Oil without Cholecalciferol 3.3 ml Migliol Oil, every two weeks for two months

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 450 patients receiving ATT, to be randomised in a 1:1 fashion (225 patients to receive vitamin D and 225 patients to receive placebo).

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Newly diagnosed smear positive pulmonary tuberculosis, including previously treated
Age between 18 to 75 years
No pre-existing liver or renal disease
Consent given for HIV testing
If HIV positive, CD4 counts >50 cells/mm3
Available for return visits as outlined in the trial protocol

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366470

Contacts

Contact: Peter Daley, MD, FRCPC	00914162222102	daleyp@univmail.cis.mcmaster.ca
Contact: Dilip Mathai, MD, FCAMS	00914162282089	dilipmathaiidtrc@yahoo.co.in

Locations

India, Tamil Nadu
Christian Medical College
Vellore, Tamil Nadu, India, 632004

Sponsors and Collaborators

Christian Medical College, Vellore, India

Dalhousie University

Investigators

Principal Investigator:

Peter Daley, MD, FRCPC

Christian Medical College, Vellore, India

More Information

TB control in India This link exits the ClinicalTrials.gov site

Study ID Numbers:	TB-VitaminD
Study First Received:	August 18, 2006
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00366470
Health Authority:	India: Ministry of Health

Study placed in the following topic categories:

Bacterial Infections
Cholecalciferol
Gram-Positive Bacterial Infections
Vitamin D
Respiratory Tract Infections
Respiratory Tract Diseases

Tuberculosis, pulmonary
Lung Diseases
Tuberculosis, Pulmonary
Ergocalciferols
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents

Micronutrients
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009