Vitamin D Supplementation in TB Prevention

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02276755
• Date of registration: 23/10/2014
• Prospective Registration: Yes
• Primary sponsor: Harvard School of Public Health
• Public title: Vitamin D Supplementation in TB Prevention
• Scientific title: Vitamin D in TB Prevention in School Age Children
• Date of first enrolment: September 2015
• Target sample size: 8851
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02276755
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Mongolia

Contacts

• Name: Davaasambuu Ganmaa, MD PhD
• Affiliation: Harvard School of Public Health

Key inclusion & exclusion criteria

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



Age minimum: 6 Years
Age maximum: 13 Years
Gender: All

Health Condition(s) or Problem(s) studied

Latent Tuberculosis

Intervention(s)

Other: Placebo

Dietary Supplement: Cholecalciferol (vitamin D3)

Primary Outcome(s)

Acquisition of latent tuberculosis infection [Time Frame: Three years]

Secondary Outcome(s)

Body composition: impedance, impedance%, fat mass fat %, and fat-free mass [Time Frame: Three years]

Incidence of dental caries [Time Frame: Three years]

Incidence of acute asthma exacerbation requiring hospitalization [Time Frame: Three years]

Attention-related behavior scores (Connors III) [Time Frame: Three years]

Bone mineral density at the radius [Time Frame: Three years]

Exam performance [Time Frame: Three years]

Self-reported pubertal development [Time Frame: Three years]

Incidence of acute respiratory infections requiring antibiotic treatment [Time Frame: Three years]

Serum 25-hydroxyvitamin D concentration [Time Frame: Three years]

Urinary metabolome profile [Time Frame: Three years]

Anthropometric outcomes (z-scores for height-for-age, weight-for-age, weight-for-height, body mass index-for-age, and waist circumference and waist-to-height ratio) [Time Frame: Three years]

Circulating and antigen-stimulated concentrations of cytokines, chemokines and other inflammatory mediators [Time Frame: Three years]

Control of asthma, allergic rhinitis and atopic dermatitis [Time Frame: Three years]

Incidence of active TB disease [Time Frame: Three years]

Incidence of acute respiratory infection requiring hospitalization [Time Frame: Three years]

Incidence of self-reported acute respiratory infection (upper, lower and both combined) [Time Frame: Three years]

Physical fitness (maximal oxygen consumption estimated from 20m shuttle run) [Time Frame: Three years]

Spirometric lung volumes (FEV1 and FVC) [Time Frame: Three years]

Gut microbiome profile [Time Frame: Three years]

Incidence of bone fracture [Time Frame: Three years]

Incidence of new asthma, allergic rhinitis and atopic dermatitis [Time Frame: Three years]

Muscle strength: grip strength and long jump distance from standing [Time Frame: Three years]

Number of days off school (total number and number due to acute respiratory infection) [Time Frame: Three years]

Secondary ID(s)

140513

Source(s) of Monetary Support

Please refer to primary and secondary sponsors