Impact of Vitamin D Supplementation on Host Immunity to Mycobacterium Tuberculosis and Response to Treatment

NCT00918086 | Completed Phase 2

• 2 other identifiers: IRB00014641Vitamin D Georgia Study
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis bacterium (TB) is a germ that can infect any part of the human body, especially the lungs. Vitamin D is a hormone present in humans that regulates blood electrolytes such as calcium and phosphate. There is new information that links vitamin D to the functioning of our immune system. The purpose of the study is to find out how vitamin D affects the immune system of patients with TB. We want to find out if correcting low vitamin D levels, in addition to getting standard therapy for TB, will help the immune system fight off TB infection more effectively. The study will be done at the Georgia National Center for Tuberculosis and Lung Diseases (NCTBLD) in Tbilisi, Republic of Georgia. 220 patients with tuberculosis and 80 family members or household contacts of patients with tuberculosis will be participating in this study. TB patients, already receiving standard TB therapy, will be randomly assigned to either receive the Vitamin D pill or a placebo for a total of sixteen weeks. Neither the subject nor the investigator will know whether the subject has received the Vitamin D or the inactive placebo.The subject will orally consume the Vitamin D/placebo tablet 3 times a week for the 1st 8 weeks (while in hospital) and then once every other week for the last 8 weeks( during out-patient visits to the hospital). The main study hypothesis is that Vitamin D supplementation helps patients with tuberculosis, who are on standard anti TB antibiotic therapy, get better faster.

Conditions

Tuberculosis

Keywords

Vitamin D; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• The primary outcome for this intent-to-treat trial is the time to Mycobacterium tuberculosis sputum culture conversion to negative

  Up to 16 weeks from therapy start date

Secondary Outcomes (1)

• Sputum culture result (positive or negative)

  8 weeks after therapy start date

Study Arms (2)

Vitamin D pill

EXPERIMENTAL

Dietary Supplement: Vitamin D pill

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Vitamin D pill DIETARY_SUPPLEMENT

Oral tablet taken for 16 weeks

Vitamin D pill

Placebo DIETARY_SUPPLEMENT

An inactive pill that looks and tastes like the Vitamin D pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is age \> 18 years;
• Patient has documented new case of smear-positive pulmonary TB;
• Patient has received ≤ 1 week of anti-TB therapy;
• The patient will receive anti-TB therapy in Tbilisi;
• Patient has provided informed consent.

You may not qualify if:

• Patient has had \> 30 days of lifetime TB therapy;
• Patient is currently pregnant or lactating;
• Patient has a history of organ transplant;
• Patient has a history of cancer in past 5 years (ineligibility criteria does not include non-melanoma skin cancer);
• Patient has a history of seizures;
• Patient has a history of hypercalcemia;
• Patient has a history of hyperparathyroidism;
• Patient has a history of sarcoidosis;
• Patient has a history of nephrolithiasis (renal stones);
• Patient has taken oral corticosteroids in the past 30 days;
• Patient is currently using cytotoxic or immunosuppressive drugs;
• Patient currently has significant renal dysfunction (defined as a serum creatinine of \>250mmol/L);
• Patient requires dialysis therapy;
• Patient has a history of cirrhosis;
• Patient is currently incarcerated;

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

National Center for tuberculosis and Lung diseases

Tbilisi, 0101, Georgia

Location

Related Publications (1)

• Tukvadze N, Sanikidze E, Kipiani M, Hebbar G, Easley KA, Shenvi N, Kempker RR, Frediani JK, Mirtskhulava V, Alvarez JA, Lomtadze N, Vashakidze L, Hao L, Del Rio C, Tangpricha V, Blumberg HM, Ziegler TR. High-dose vitamin D3 in adults with pulmonary tuberculosis: a double-blind randomized controlled trial. Am J Clin Nutr. 2015 Nov;102(5):1059-69. doi: 10.3945/ajcn.115.113886. Epub 2015 Sep 23.

  PMID: 26399865 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Thomas R Ziegler, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2014
• Last Updated: July 11, 2014

Record last verified: 2014-07

Locations

GE (1)