Vitamin D Supplementation in TB Prevention

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: Latent Tuberculosis

Treatments: Dietary Supplement: Cholecalciferol (vitamin D3); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02276755

140513

Details and patient eligibility

About

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 hypothesize that (1) vitamin D supplementation will reduce risk of acquisition of LTBI, (2) vitamin D supplementation will safely reduce risk of developing active TB and improve other secondary efficacy outcomes, and (3) children with the lowest vitamin D status at baseline will gain most from the intervention.

Enrollment: 8,851 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Boys or girls aged 6 to 13 years at enrolment
2. Attending participating school in Ulaanbaatar at enrolment
3. Child gives informed assent to participate in the study
4. Child's parent/legal guardian gives informed consent for child to participate in study

Exclusion criteria

1. Chronic medical conditions
2. Presence of LTBI on screening, as evidenced by a positive QFT-G
3. Clinical signs of rickets, or diagnosis of any other condition requiring vitamin D supplementation
4. Known primary hyperparathyroidism or sarcoidosis
5. Taking immunosuppressant or cytotoxic therapy, or vitamin D supplement > 400IU / day
6. Plans to move away from study area within 3 years of enrolment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,851 participants in 2 patient groups, including a placebo group

Intervention: 1

Active Comparator group

Description:

Dietary Supplement: Cholecalciferol (vitamin D3)

Treatment:

Dietary Supplement: Cholecalciferol (vitamin D3)

Placebo Comparator: 2

Placebo Comparator group

Description:

Dietary Supplement: Placebo

Treatment:

Other: Placebo