Status:
COMPLETED
Vitamin D Supplementation in TB Prevention
Lead Sponsor:
Harvard School of Public Health (HSPH)
Conditions:
Latent Tuberculosis
Eligibility:
All Genders
6-13 years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to determine whether vitamin D supplementation reduces risk of acquiring latent tuberculosis infection (LTBI) in school age children in Mongolia. The investigators h...
Eligibility Criteria
Inclusion
- Boys or girls aged 6 to 13 years at enrolment
- Attending participating school in Ulaanbaatar at enrolment
- Child gives informed assent to participate in the study
- Child's parent/legal guardian gives informed consent for child to participate in study
Exclusion
- Chronic medical conditions
- Presence of LTBI on screening, as evidenced by a positive QFT-G
- Clinical signs of rickets, or diagnosis of any other condition requiring vitamin D supplementation
- Known primary hyperparathyroidism or sarcoidosis
- Taking immunosuppressant or cytotoxic therapy, or vitamin D supplement \> 400IU / day
- Plans to move away from study area within 3 years of enrolment
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
8851 Patients enrolled
Trial Details
Trial ID
NCT02276755
Start Date
September 1 2015
End Date
June 1 2020
Last Update
July 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mongolian Health Initiative
Ulaanbaatar, Mongolia