Replacement of Vitamin D in Patients With Active Tuberculosis

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Tuberculosis is a global public health problem. One third of the world's population is infected with tuberculosis (TB) with almost 2 million deaths per year globally. According to the WHO, Pakistan ranks 8th amongst the 22 high TB burden countries, with an estimated prevalence is 263 cases /100,000 populations.

In spite of effective therapy for drug sensitive TB, treatment failure occurs frequently leading to concerns for the emergence of multi-drug resistant (MDR) and extensively drug resistant (XDR) mycobacterial strains. Therefore in the recent years, interest has been generated regarding the role of adjuvant immunomodulating therapy for the treatment of TB.

WHO has classified tuberculosis by disease severity into 3 distinct categories; mild, moderate and severe according to clinical presentations and host factors. Severity of disease has been linked to mycobacterium genotypes and with host factors such as vitamin D deficiency

Vitamin D is a hormone produced by the body in response to sun exposure. Independent of it's effects on bone mineralization, vitamin D is recognized to have numerous immune modulating effects; some specific to mycobacterium tuberculosis. Therefore vitamin D may enhance the host immune responses against the pathogen. Vitamin D status can be accurately determined by measuring the serum levels of 25-(OH) D3. A recent systemic review and meta-analysis explored the association between low serum vitamin D and risk of active tuberculosis and concluded that patients with tuberculosis have lower serum levels of vitamin D than healthy controls when matched for sex, age, ethnicity, diet and geographical location.

Vitamin D deficiency is not a life threatening condition. It usually is unrecognized or can present with generalized 'aches and pains' due to osteomalacia. The recommended dose for treatment of vitamin D deficiency is 200,000 IU/ month or 50,000 IU/ week, both given for 2 months or until the serum vitamin D level is > 30 ng/ml. Bone mineral density changes are usually completed by 10 weeks of treatment.

The investigators hypothesize that by replacing vitamin D in patients with active pulmonary tuberculosis, the 'Time to Recovery' can be shortened.Our aims are to determine whether replacing patients with insufficient and deficient levels of vitamin D affects the clinical outcome of the disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Collaborator: Dow University of Health Sciences
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Adults (≥16 years on 1st March 2009) Males and Nonpregnant females

• Active Pulmonary Tuberculosis diagnosed by Sputum Smear positivity for Acid fast bacilli (AFB)

• Diagnosis within one week of inclusion into study

• Not already on antituberculous treatment

• Not receiving vitamin D replacement or supplementation

Exclusion Criteria:

• History of having been treated with antimycobacterial therapy for < 6 months or with < 4 first-line anti-tuberculous drugs

• Extra- pulmonary TB

• Immune suppressed; with HIV infection, hepatic, renal failure, malignancy, diabetes mellitus

• Sarcoidosis, hyperparathyroidism

• Already on or requiring corticosteroids, immunosuppressive agents, thiazide diuretics

• Breast feeding or pregnant

• Symptomatic cardiac disease

• Seriously ill or moribund patients with advanced respiratory impairment (cor pulmonale, hypercapnia, respiratory acidosis, congestive cardiac failure)

• Allergy/sensitivity to study drugs or their formulations.

• Concomitant use of drugs known to interfere with vitamin D levels; phenytoin, phenobarbital, carbamazepine, theophylline

• Inability or unwillingness of subject or legal guardian/representative to give written informed consent.