Vitamin D in Active Tuberculosis (TB) Study - Full Text View

Sponsored by:	Emory University
Information provided by:	Atlanta VA Medical Center
ClinicalTrials.gov Identifier:	NCT00788320

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

MedlinePlus related topics: Calcium Tuberculosis

Drug Information available for: Vitamin D Ergocalciferol Cholecalciferol

U.S. FDA Resources

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

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 ]

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
Placebo: Placebo Comparator Placebo three times a week for 8 weeks	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

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

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

Contacts

Contact: Vin Tangpricha, MD, PhD

404-727-7254

vin.tangpricha@emory.edu

Locations

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.

Sponsors and Collaborators

Emory University

More Information

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

Keywords provided by Atlanta VA Medical Center:

Tuberculosis
vitamin D
immune system

Study placed in the following topic categories:

Bacterial Infections
Cholecalciferol
Gram-Positive Bacterial Infections
Vitamin D

Ergocalciferols
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents

Micronutrients
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009