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Vitamin D in Active Tuberculosis (TB) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00788320
Recruitment Status : Withdrawn (Inadequate enrollment)
First Posted : November 10, 2008
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Tuberculosis Drug: Vitamin D3 Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antimicrobial Peptide LL-37 (Cathelicidin) Production in Active Tuberculosis Disease: Role of Vitamin D Supplementation
Study Start Date : October 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo three times a week for 8 weeks
Drug: Placebo
Placebo three times a week for 8 weeks

Experimental: Cholecalciferol
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

Primary Outcome Measures :
  1. LL-37 level [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Sputum Conversion [ Time Frame: 8 weeks ]
  2. 25-hydroxyvitamin D and serum calcium [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Study subjects must be patients with newly diagnosed laboratory confirmed pulmonary tuberculosis (i.e., no previous history of treatment for TB for more than 30 days). Those enrolled should not have received more than 1 week of antituberculosis therapy prior to enrollment.
  • Study subjects must agree to participate in the study and provide written informed consent
  • Histology: not applicable
  • Sites: Emory University affiliated hospitals (including Emory University Hospital, Emory Crawford Long Hospital, Grady Memorial Hospital), and metropolitan Atlanta health departments including the Fulton County Department of Health and Wellness and the DeKalb County Board of Health as well as additional health departments in the Metropolitan Atlanta area.
  • Stage of Disease: pulmonary tuberculosis patients who have completed less than 1 week of TB therapy
  • Age: Study subjects must be > 18 years old
  • Performance Status: study subjects will be patients with newly diagnosed laboratory confirmed pulmonary TB who have completed < 1 week of anti-TB therapy and who are able to provide written informed consent
  • Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English. An additional consent form will be provided to subjects who agree to long term storage of their blood, saliva, and sputum samples for future use by the investigators of this study. For subjects who do not speak English, a short consent form will be used to obtain informed consent, which will be available in the the 10 most commonly encountered languages in the greater Atlanta area after English. The short form will be used in conjunction with an interpreter who will assist in translating and discussing the content of the long form prior to the subjects' signing of the short form.

Exclusion Criteria:

  • Age < 18years
  • Prior anti-microbial drug treatment of tuberculosis for longer than 1 week
  • Prior other diseases: patients with prior disorders potentially affecting vitamin D levels and metabolism of calcium and phosphate will be excluded. Pregnant or lactating women are ineligible for this study. We plan to exclude patients with any known disorders of the endocrine system affecting vitamin D metabolism, including: hyperparathyroidism, known history of nephrolithiasis, any documented malignancies, and advanced renal disease. Patients with prior disorders that may potentially affect cathelicidin levels will be excluded as well. These diseases include atopic dermatitis (eczema) and hematologic malignancies (leukemia, lymphoma, among others)
  • Infection: not applicable
  • Hematologic, renal and hepatic, and other values that preclude entry into the study: serum creatinine of >1.5 mg/dL to assist with exclusion of patients with renal disease. Patients with baseline calcium level >10.5 mg/dL will be excluded to assist with exclusion of pre-existing disorders of vitamin D and calcium metabolism (see Section C above)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00788320

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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Atlanta VA Medical Center
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Responsible Party: Vin Tangpricha, Associate Professor, Atlanta VA Medical Center Identifier: NCT00788320    
Other Study ID Numbers: Vitamin D in TB
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012
Keywords provided by Vin Tangpricha, Atlanta VA Medical Center:
vitamin D
immune system
Additional relevant MeSH terms:
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Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents