Replacement of Vitamin D in Patients With Active Tuberculosis
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Aga Khan University
Collaborator:
Dow University of Health Sciences
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins