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Vitamin D in Active Tuberculosis (TB) Study

This study has been withdrawn prior to enrollment.
(Inadequate enrollment)
Sponsor:
Information provided by (Responsible Party):
Vin Tangpricha, Atlanta VA Medical Center
ClinicalTrials.gov Identifier:
NCT00788320
First received: November 7, 2008
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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
Tuberculosis
Drug: Vitamin D3
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antimicrobial Peptide LL-37 (Cathelicidin) Production in Active Tuberculosis Disease: Role of Vitamin D Supplementation

Resource links provided by NLM:


Further study details as provided by Atlanta VA Medical Center:

Primary Outcome Measures:
  • LL-37 level [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sputum Conversion [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 25-hydroxyvitamin D and serum calcium [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788320

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Atlanta VA Medical Center
  More Information

No publications provided

Responsible Party: Vin Tangpricha, Associate Professor, Atlanta VA Medical Center
ClinicalTrials.gov Identifier: NCT00788320     History of Changes
Other Study ID Numbers: Vitamin D in TB
Study First Received: November 7, 2008
Last Updated: January 18, 2012
Health Authority: United States: Federal Government

Keywords provided by Atlanta VA Medical Center:
Tuberculosis
vitamin D
immune system

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014