NCT04593524

Brief Summary

Recent studies showed that vitamin D and A has an effect in improving sputum conversion in tuberculosis. This study aims to find out the effect of vitamin D 1000 IU and A 6000 IU supplementation on Tuberculosis patients with vitamin D receptor gene polymorphism, who live in North Sumatera, Indonesia. This study is a randomized control clinical trial, with 48 tuberculosis patients with vitamin D receptor gene polymorphism which are TaqI and FokI participating, divided into two groups, each with 24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU, and control group (C) which only receives nutritional counseling for 28 days. Patients who participated was found to be heterozygous with TaqI (T\>C) or FokI (C\>T) genotype variants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

September 29, 2020

Last Update Submit

October 13, 2020

Conditions

Tuberculosis

Keywords

25(OH)D serumcalciumcounselingFokIretinolTaqI

Outcome Measures

Primary Outcomes (3)

  • vitamin D

    25(OH)D serum level

    up to 4 weeks

  • vitamin A

    vitamin A serum level

    up to 4 weeks

  • beta carotene

    beta carotene

    up to 4 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU

Dietary Supplement: vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling

Counseling Group

ACTIVE COMPARATOR

24 participants which only receives nutritional counseling for 28 days

Other: nutritional Counseling

Interventions

vitamin D 1000 IU and A 6000 IU supplementation and nutritional counselingDIETARY_SUPPLEMENT

24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU

Treatment Group
nutritional CounselingOTHER

control group (C) which only receives nutritional counseling for 28 days

Counseling Group

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMrs / Miss
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatra, 20155, Indonesia

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Vitamin DDietary SupplementsNutrition Assessment

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 20, 2020

Study Start

May 14, 2019

Primary Completion

August 15, 2019

Study Completion

September 22, 2019

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

ID(1)