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Vitamin D Suplementation in TB Prevention

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ClinicalTrials.gov Identifier: NCT02276755
Recruitment Status : Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ganmaa Davaasambuu, Harvard School of Public Health

Brief Summary:
The goal of this clinical trial is to investigate the preventive role of vitamin D supplementation in school age children in a high transmission setting. The investigators hypothesis is that (1) vitamin D supplementation will reduce rate of acquisition of LTBI, (2) vitamin D supplementation will lead to greater reductions in active TB incidence, and (3) children with the lowest vitamin D status at baseline will gain most from the intervention.

Condition or disease Intervention/treatment Phase
Latent Tuberculosis Dietary Supplement: cholecalciferol (vitamin D) Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D in TB Prevention in School Age Children
Actual Study Start Date : September 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention: 1
Dietary Supplement: cholecalciferol (vitamin D)
Dietary Supplement: cholecalciferol (vitamin D)
14000 IU vitamin D3 weekly Experimental group will receive vitamin D supplement (Tishcon, USA).

Placebo Comparator: Placebo Comparator: 2
Dietary Supplement: Placebo
Other: Placebo
Placebo group will receive placebo (Tishcon, USA) weekly.




Primary Outcome Measures :
  1. The primary outcome is acquisition of latent tuberculosis (LTBI) as evidenced by conversion of the QuantiFERON-TB Gold in-tube assay test result from negative to positive. [ Time Frame: Three years ]
    Differences in the proportion of children who acquire LTBI during the 3 year period who were randomized to placebo will be compared to those randomized to the Vitamin D regimen.



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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy children ages between 6 and 13 years, enrolled in participating schools
  2. Not currently TB infected, tested by QFT-G test.
  3. Pupil gives written informed assent for participation trial
  4. Pupil's parent / guardian give written informed consent for participation.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276755


Locations
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Mongolia
Mongolian Health Initiative
Ulaanbaatar, Mongolia
Sponsors and Collaborators
Harvard School of Public Health

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Responsible Party: Ganmaa Davaasambuu, Assistant Professor, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02276755     History of Changes
Other Study ID Numbers: 140513
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents