Pulmonary Tuberculosis and Vitamin D

NCT00507000 | Unknown Phase 3 DMC

• 1 other identifier: BT/pr7898/Med/14/1179/2006
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to convert from sputum positivity to negativity

  Two months after the last recruitment

Secondary Outcomes (1)

• 1 To study the relapse rate and safety assessment 2 To study the effect of Vitamin D supplementation on the pattern of effector immune function in patients suffering from pulmonary Tuberculosis.

  Three years

Study Arms (2)

A, Cholecalciferol

ACTIVE COMPARATOR

A 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

Drug: Cholecalciferol

Vitamin D and Tuberculosis

PLACEBO COMPARATOR

B, Lactose

Drug: Lactose granules

Interventions

Cholecalciferol DRUG

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

Also known as: Vitamin D

A, Cholecalciferol

Lactose granules DRUG

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

Vitamin D and Tuberculosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients of either sex with Newly diagnosed sputum positive pulmonary TB cases
• Aged between 18 to 60 yrs

You may not qualify if:

• Category II pulmonary TB and multi-drug resistant TB (MDR-TB) patients
• Presence of secondary immunodeficiency states : HIV, organ transplantation, diabetes mellitus, malignancy, treatment with corticosteroids
• Hepatitis B and C positivity
• Patients with extrapulmonary TB and/or patients requiring surgical intervention
• Currently receiving cytotoxic therapy, or have received it within the last 3 months
• Pregnancy and lactation
• Patients with a known seizure disorder
• Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease
• Patients with abnormal renal functions (serum creatinine more than 2 mg/dl; more than 2+ proteinuria)
• Patients with abnormal hepatic functions (bilirubin = 1.5 mg/dl; AST, ALT, SAP \> 1.5 times above upper limit
• Patients with hematological abnormalities (WBC lesser than or equal to 3000/mm3; platelet count less than or equal to 100,000/mm3)
• Seriously ill and moribund patients with complications : tachypnoea, chronic cor pulmonale, congestive cardiac failure, BMI\<15, severe hypoalbuminemia
• Patients unable to comply with the treatment regimen
• Patients with history of alcohol or drug abuse

Sponsors & Collaborators

• Indian Council of Medical Research: lead
• Ministry of Science and Technology, India: collaborator

Study Sites (1)

Depratment of Endocrinology;Medicine, All India Institute of Medical sciences, and DBT

Delhi, New Delhi, 110029, India

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Ravinder Goswami, MD, DM

  Associate Professor, Depratment of Endocrinology and Metabolism, All India Institute of Medical Sciences, New delhi 110029

  PRINCIPAL INVESTIGATOR

• SK Sharma, MD, PHD

  Head, Depratment of Medicine, All India Institute of Medical Sciences, New Delhi 110029

  PRINCIPAL INVESTIGATOR

• DK Mitra, MBBS, PhD

  Associate professor, Department of Transplant immunology and immunogenetics, All India Institute of Medicasl Sciences, New delhi 110029, India

  PRINCIPAL INVESTIGATOR

• Urvashi B Singh, MD, PhD

  Assistant Professor, Deprtament of Microbiology, All India Institute of Medical Sciences, new delhi 110029

  PRINCIPAL INVESTIGATOR

• Nandita Gupta, PhD

  Additional Porfessor, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi 110029, India

  PRINCIPAL INVESTIGATOR

• Bindu Dey, PhD.

  Adviser, Department of Biotechnology, Lodhi Road, New Delhi-110003, India

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 23, 2007
• First Posted: July 25, 2007
• Study Start: May 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2012
• Last Updated: January 27, 2011

Record last verified: 2009-07

Locations

IN (1)