Tuberculosis, Pulmonary Clinical Trial
— SUCCINCTOfficial title:
A Randomized, Placebo-Controlled, Double-Blinded, 250-Subject Clinical Trial of Vitamin D Replacement in Patients With Pulmonary Tuberculosis
Verified date | June 2011 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Pakistan: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 259 |
Est. completion date | December 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Pakistan | Abbasi Shaheed Hospital | Karachi | Sind |
Pakistan | Aga Khan University | Karachi | Sind |
Pakistan | Malir Chest Clinic | Karachi | Sind |
Pakistan | Ojha Istitute of Chest Diseases | Karachi | Sind |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | Dow University of Health Sciences |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure difference in Clinical RESPONSES between test and control groups after treatment with vitamin D | 12 weeks | No | |
Secondary | To assess the effects of vitamin D replacement on cytokine responses | Stimulated and unstimulated IFN-gamma responses between the two groups will be compared | 12 weeks | No |
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