Replacement of Vitamin D in Patients With Active Tuberculosis (SUCCINCT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Placebo-Controlled, Double-Blinded, 250-Subject Clinical Trial of Vitamin D Replacement in Patients With Pulmonary Tuberculosis|
- To measure difference in Clinical RESPONSES between test and control groups after treatment with vitamin D [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To assess the effects of vitamin D replacement on cytokine responses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Stimulated and unstimulated IFN-gamma responses between the two groups will be compared
|Study Start Date:||October 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Experimental: Cholecalciferol (Vitamin D)
Intramuscular injection of VITAMIN D, 600,000 UNITS WILL BE GIVEN TO THE TEST SUBJECTS AT WEEK 0 and at week 4 OF the TRIAL
Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
Other Name: VITAMIN D
Placebo Comparator: SALINE, INTRAMUSCULAR INJECTION
NORMAL SALINE INJECTION WILL BE GIVEN TO THE CONTROL SUBJECTS at week 0 and week 4 of the trial
Drug: Saline injection
normal saline, intramuscular preperation,given in 2 doses at week 0 and week 4 of trial
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130311
|Ojha Istitute of Chest Diseases|
|Karachi, Sind, Pakistan, 74800|
|Abbasi Shaheed Hospital|
|Karachi, Sind, Pakistan, 74812|
|Malir Chest Clinic|
|Karachi, Sind, Pakistan, 74831|
|Aga Khan University|
|Karachi, Sind, Pakistan, 74800|
|Principal Investigator:||Nawal Salahuddin, MBBS,FCCP||Aga Khan University|