Tuberculosis Clinical Trial
Official title:
Role of Oral Vitamin D as an Adjunct Therapy in Category I Pulmonary Tuberculosis Along With Assessment of Immunological Parameters. (Double-blind, Randomized, Placebo-Controlled, Clinical Trial)
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.
Tuberculosis and vitamin D deficiency are important public health problems in India. In
recently published studies from our center, up to 90% of the apparently healthy subjects in
Delhi were classified either as as vitamin D insufficient or deficient by using serum
25(OH)D cut off levels of 20 ng/ml and 32 ng/ml respectively. Before the advent of effective
antitubercular therapy, patients with tuberculosis were advised treatment and rest at
sanatorium where sunshine was available in plenty. In the western literature, 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. A few pilot
studies have shown that sputum conversion rate is higher in patients with tuberculosis
supplemented with vitamin D.
In the above context the mechanisms linking vitamin D deficiency and its effect on
tuberculosis are currently under investigation. In order to understand the link two types of
studies have been conducted (a) clinical studies associating vitamin D deficiency and
tuberculosis and (b) in-vitro assessment of molecular immune changes related to vitamin D
exposure. With the currently available knowledge, the linkage between the two disorders is
being explained by the broad role of vitamin D deficiency in modulation of cell-mediated
immunity.
Patients with military tuberculosis are characterized by decreased levels of Th1 cytokines
and increased levels of IL-10 compared with the healthy infected and noninfected controls.
Current literature suggests that long-term control of M. tuberculosis infection is
associated with elevated Th1 responses and concomitant inhibition of the Th2 response
Peripheral blood mononuclear cells have been shown to express vitamin D receptors.
Incubation of macro¬phages with physio¬logical concentration of 1,25 (OH)D [10-9M] results
in inhibition of intracellular growth of Mycobacterium tuberculosis.
1,25-dihydroxycholecalciferol, has significant immunomodulatory effects leading to (a) shift
in cytokine profile of T-helper (Th1 to Th2) and (b) reduced antigen presentation, reduced
production of Th1-promoting cytokines, reduced expression of co-stimulatory molecules in the
antigen-presenting cell. In addition, it was demonstrated that the addition of vitamin D3
derivatives inhibits the differentiation of IFN-gamma-producing Th1 cells while it augments
the differentiation of IL-4- or IL-10-producing Th2 cells.
There are no systematic data from our country assessing association between vitamin D
deficiency and tuberculosis and the possible role of vitamin D related modulation in the
tuberculosis specific cellular immune response. The present study has been planned with the
following hypothesis
Hypothesis: Patients with pulmonary tuberculosis and vitamin D deficiency when treated with
vitamin and antitubercular therapy are likely to show early sputum conversion and immune
response favoring resolution of tuberculosis
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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