NCT05073965

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

August 27, 2021

Last Update Submit

October 11, 2021

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (5)

  • Change in Cough Symptom

    Resolution time for coughing, parents take notes every day.

    Baseline, every month in month 1-6

  • Change in Fever Symptom

    Resolution time for fever, parents take notes every day.

    Baseline, every month in month 1-6

  • Change in Body weight

    Measurement of body weight

    Baseline, every 2 weeks in month 1 and month 2, every month in month 3-6.

  • Change in Height

    Measurement of height

    Baseline, every 2 weeks in month 1 and month 2, every month in month 3-6.

  • Change in Body Mass Index

    Calculation of Body Mass Index

    Baseline, every 2 weeks in month 1 and month 2, every month in month 3-6.

Secondary Outcomes (3)

  • Vitamin D level

    Baseline and 6 months after intervention

  • Alanine Transaminase

    Baseline and 6 months after intervention

  • Alkaline Phosphatase

    Baseline and 6 months after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Subject receive a 1000IU vitamin D supplement dose daily for 6 months

Dietary Supplement: Vitamin D

Placebo group

PLACEBO COMPARATOR

Subject receive a placebo daily for 6 months

Other: Placebo

Interventions

Vitamin DDIETARY_SUPPLEMENT

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

Intervention Group
PlaceboOTHER

Subject were assigned to receive a placebo

Placebo group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6 to 18 years old
  • Newly diagnosed with pulmonary tuberculosis
  • Vitamin D insufficiency

You may not qualify if:

  • Children with a history of liver abnormalities
  • Children with a history of kidney abnormalities
  • Immunocompromised children
  • Children who has already received vitamin D supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RS Bethesda

Bengkayang, West Borneo, 79211, Indonesia

Location

Related Publications (1)

  • Tamara L, Kartasasmita CB, Alam A, Gurnida DA. Effects of Vitamin D supplementation on resolution of fever and cough in children with pulmonary tuberculosis: A randomized double-blind controlled trial in Indonesia. J Glob Health. 2022 Feb 18;12:04015. doi: 10.7189/jogh.12.04015. eCollection 2022.

    PMID: 35198149DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Lianda Tamara, MD,Paed

    Universitas Padjadjaran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2021

First Posted

October 12, 2021

Study Start

December 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)