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Vitamin D Supplementation Effect In Children With Pulmonary Tuberculosis Treatment

NCT05073965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-10-12

No results posted yet for this study

Summary

This study aims to evaluate the vitamin D supplementation effect to improve clinical outcomes in children with pulmonary tuberculosis treatment. This randomized, double-blind control trial with a cohort design was conducted in West Borneo from December 2020 - July 2021. A Total 84 patients met the inclusion criteria; aged 6 to 18 years old, newly diagnosed with pulmonary tuberculosis with vitamin D insufficiency. Only 80 patients completed the six months follow-up. The intervention was 1,000 IU vitamin D or placebo for six months treatment. Comparison of clinical conditions and nutritional status are analyzed statistically.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Subjects were assigned to receive a 1000IU vitamin D supplement dose

OTHER

Placebo

Subject were assigned to receive a placebo

Sponsors & Collaborators

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Lianda Tamara, MD,Paed · Universitas Padjadjaran

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-07-30
Completion
2021-07-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05073965 on ClinicalTrials.gov