Role of Vitamin D in Innate Immunity to Tuberculosis
This study has been completed.
Sponsor:
Harvard School of Public Health
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01244204
First received: November 15, 2010
Last updated: August 1, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The investigators proposed a pilot study preparatory to developing a randomized trial of vitamin D for the prevention of TB infection. The specific aims are presented below:
- To recruit subjects, obtain consent, distribute vitamin D supplements to the children in the schools, obtain blood samples and transport them to the United States.
- To test the hypothesis that daily vitamin D supplementation will increase plasma levels of 25(OH)D, and restore TLR-induced antimicrobial activity in monocytes/macrophages tested in vitro.
| Condition | Intervention |
|---|---|
|
Vitamin D Deficiency Tuberculosis |
Dietary Supplement: Vitamin D Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Vitamin D Supplementations as Adjunct to Anti-tuberculosis Drugs in Mongolia |
Resource links provided by NLM:
Further study details as provided by Harvard School of Public Health:
Primary Outcome Measures:
- Serum vitamin D levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Tuberculin Skin Test conversion [ Time Frame: 6 monhs ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vitamin D |
Dietary Supplement: Vitamin D
Daily dose of 800IU of vitamin D
|
| Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Identically appearing capsules
|
Eligibility| Ages Eligible for Study: | 10 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Eligible subjects will be children age 12 to 15 years inclusive in public school, located in Songino-Khairhan district, who are residents of Ulaanbaatar, and whose parents have given informed consent and who accent to participate in the study.
Exclusion Criteria:
- Individuals with pre-existing calcium, parathyroid conditions, or type I diabetes, sarcoidosis, or who require chronic diuretic therapy including calcium channel blockers, or who are cognitively impaired.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided by Harvard School of Public Health
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ganmaa Davaasambuu, Assistant Professor of Medicine, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01244204 History of Changes |
| Other Study ID Numbers: | 1 K99 HL089710-01A1 |
| Study First Received: | November 15, 2010 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Harvard School of Public Health:
|
vitamin D deficiency tuberculin sin test immunity tuberculosis |
Additional relevant MeSH terms:
|
Tuberculosis Vitamin D Deficiency Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Avitaminosis Deficiency Diseases Malnutrition |
Nutrition Disorders Vitamin D Ergocalciferols Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013