Pulmonary Tuberculosis and Vitamin D

Summary

Tuberculosis and vitamin D deficiency are important public health problems in India. Before the advent of effective antitubercular therapy, patients with tuberculosis were advised treatment and rest at sanatorium where sunshine was available in plenty. There have been reports associating vitamin D deficiency with tuberculosis in terms of incidence and beneficial response following addition of vitamin D to antitubercular therapy. Sputum AFB conversion rate is higher in patients with tuberculosis supplemented with vitamin D. The present study would systematically assess role of adjunct vitamin D therapy (cholecalciferol) in patients with pulmonary tuberculosis.

Conditions

• Tuberculosis

Interventions

DRUG

Cholecalciferol

Drug: Cholecalciferol Drug: Cholecalciferol 60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate for first two months followed by 1 gm of elemental calcium in form of calcium carbonate daily cholecalciferol (vitamin D)60,000 IU per month for the next four months Arms: A, Cholecalciferol

DRUG

Lactose granules

Drug: Lactose placebo Lactose placebo granules in identical sachet given weekly and two lactose tablets for first two months followed one sachet of placebo granules every month and two tablets of lactose containing placebo tablets taken daily for next four months

Sponsors & Collaborators

• Ministry of Science and Technology, India

  collaborator OTHER_GOV

• Indian Council of Medical Research

  lead OTHER_GOV

Principal Investigators

• Ravinder Goswami, MD, DM · Associate Professor, Depratment of Endocrinology and Metabolism, All India Institute of Medical Sciences, New delhi 110029

• SK Sharma, MD, PHD · Head, Depratment of Medicine, All India Institute of Medical Sciences, New Delhi 110029

• DK Mitra, MBBS, PhD · Associate professor, Department of Transplant immunology and immunogenetics, All India Institute of Medicasl Sciences, New delhi 110029, India

• Urvashi B Singh, MD, PhD · Assistant Professor, Deprtament of Microbiology, All India Institute of Medical Sciences, new delhi 110029

• Nandita Gupta, PhD · Additional Porfessor, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi 110029, India

• Bindu Dey, PhD. · Adviser, Department of Biotechnology, Lodhi Road, New Delhi-110003, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-05-31

Primary Completion

2010-09-30

Completion

2012-09-30

Countries

• India

Study Locations