Tuberculosis Clinical Trial
Official title:
Effect of Multivitamin Supplements on Clinical and Immunological Response in Childhood Tuberculosis
Verified date | March 2015 |
Source | Harvard School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to see whether children who take vitamins along with the standard medicine for tuberculosis (TB) recover better and quicker than children who take only the standard medicine for TB. Four hundred children ages 6 weeks-5 years, who have been diagnosed with tuberculosis, will be enrolled. They will be followed for 2 months after treatment for TB. Study procedures may include blood draws, Tuberculin Skin Tests, body measurements, gastric aspirates (removal of stomach fluid), physical exams, and questionnaires. This study will occur in Tanzania.
Status | Terminated |
Enrollment | 40 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Weeks to 5 Years |
Eligibility |
Inclusion Criteria: - Loss of more than 10% of maximum weight or failure to gain weight for 2 months. - Having cough with wheeze for 4 weeks or more. - History of household contact with a probable or confirmed tuberculosis case in the past 6 months. - Pyrexia of unknown origin. - Painless swelling in a group of cervical lymph nodes. - Children who were diagnosed with TB in the past 5 years and have received anti-tuberculosis therapy for a period less than 4 weeks. Exclusion Criteria: -Children who have been treated with anti-tuberculosis therapy exceeding 4 weeks in the past one year will not be eligible for entry into the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Tanzania | Muhimbili University, College of Health Sciences | Dar Es Salaam |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health | National Institute of Allergy and Infectious Diseases (NIAID) |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | weight gain in childhood tuberculosis | 2 months after start of anti-tuberculosis therapy. | No | |
Secondary | clearance of chest x-ray in childhood tuberculosis | 2 months after start of anti-tuberculosis therapy | No | |
Secondary | immunological parameters: ex-vivo lymphocyte proliferation; cytokines production including IL-2, IL-12, TNF - alpha, interferon-gamma; and CD4 and CD8 T-lymphocyte counts | 2 months after start of anti-tuberculosis therapy | No |
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