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Sponsored by: |
Emory University |
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Information provided by: | Atlanta VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00788320 |
Tuberculosis is a disease caused by a bacterium (a germ) that can cause illness in any organ of the body, but most frequently causes disease of the lungs. TB is short for tuberculosis. Treating TB requires several months (usually 6 months) of treatment, with the first 2 months being intensive treatment with usually four medicines. Treatment is needed to keep the infection from getting worse and to prevent death from TB.
Vitamin D is a hormone present in the human body to manage levels of some essential electrolytes such as calcium and phosphate. Vitamin D is important for bone formation and prevention of bone breakdown (osteoporosis) as the investigators age. There is also new evidence that links vitamin D to function of our immune system as well. Even though our bodies can make vitamin D and can also obtain vitamin D from our diet, most adults, especially patients with tuberculosis have low vitamin D levels (are vitamin D deficient) that need to be corrected. Full correction of low vitamin D levels requires 6 weeks or more of weekly vitamin D supplements. There are several benefits to correcting vitamin D deficiency (better bone health, better balance of calcium and phosphate), but it is not known whether correcting vitamin D deficiency will lead to a better immune response to tuberculosis. Preliminary data does suggest that vitamin D increases the levels of an antimicrobial molecule (cathelicidin LL-37) in the body, possibly leading to better immunity against tuberculosis. The primary objective of this pilot study is to assess the relationship of vitamin D levels in patients with active pulmonary tuberculosis to levels of LL-37 cathelicidin in sputum and whole blood. The results of this study are needed in preparation for larger studies that will evaluate the role of vitamin D supplementation as adjunctive therapy to standard medical treatment for tuberculosis.
Condition | Intervention |
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Tuberculosis |
Drug: Vitamin D3 Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Antimicrobial Peptide LL-37 (Cathelicidin) Production in Active Tuberculosis Disease: Role of Vitamin D Supplementation |
Estimated Enrollment: | 80 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Placebo: Placebo Comparator
Placebo three times a week for 8 weeks
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Drug: Placebo
Placebo three times a week for 8 weeks
|
Cholecalciferol: Experimental
Vitamin D3 50,000 IU three times a week for 8 weeks
|
Drug: Vitamin D3
Vitamin D3 50,000 IU three times a week for 8 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vin Tangpricha, MD, PhD | 404-727-7254 | vin.tangpricha@emory.edu |
United States, Georgia | |
Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Alexandra V Yamshchikov, M.D. 404-616-0606 ayamshc@emory.edu | |
Sub-Investigator: Alexandra V Yamshchikov, M.D. |
Responsible Party: | Emory University School of Medicine ( Vin Tangpricha ) |
Study ID Numbers: | Vitamin D in TB |
Study First Received: | November 7, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00788320 |
Health Authority: | United States: Federal Government |
Tuberculosis vitamin D immune system |
Bacterial Infections Cholecalciferol Gram-Positive Bacterial Infections Vitamin D |
Ergocalciferols Mycobacterium Infections Tuberculosis |
Growth Substances Vitamins Physiological Effects of Drugs Bone Density Conservation Agents |
Micronutrients Pharmacologic Actions Actinomycetales Infections |