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Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
SCAR Porridge
Counseling
Sponsored by
Universitas Sumatera Utara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tuberculosis focused on measuring polymorphism, porridge, vitamin D, biomolecular

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants which have newly diagnosed with lung tuberculosis with an acid fast bacilli (AFB) result (+), aged 18-60 years, with a heterozygote genotype test performed on one of the genes TaqI and FokI, willing to participate in the study, and provided informed consent

Exclusion Criteria:

  • Participants which being pregnant and/or a breastfeeding mother

Sites / Locations

  • Faculty of Medicine Universitas Sumatera Utara

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SCAR Porridge Group

Counseling Group

Arm Description

There were 22 subjects in the intervention group (I) who received 50 g of SCAR porridge once per day, along with dietary counseling.

21 subjects in the control group (C) who only received dietary counseling

Outcomes

Primary Outcome Measures

Vitamin D
25(OH)D Serum level
Calcium
Calcium Serum level

Secondary Outcome Measures

albumin
albumin serum level
Hs CRP
Hs CRP serum level
blood glucose
blood glucose serum level

Full Information

First Posted
September 29, 2020
Last Updated
October 27, 2020
Sponsor
Universitas Sumatera Utara
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1. Study Identification

Unique Protocol Identification Number
NCT04613258
Brief Title
Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications
Official Title
Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 11, 2019 (Actual)
Primary Completion Date
August 17, 2019 (Actual)
Study Completion Date
September 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sumatera Utara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Tuberculosis patients that have complications (e.g., diabetes mellitus and human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)) who live in tropical regions experience vitamin D deficiency, especially in North Sumatra, Indonesia. The presence of vitamin D receptor (VDR) polymorphism genes, TaqI and FokI, is one of the predisposing factors, as is high levels of inflammatory markers, also indicating disease progression and malnutrition. This study aims to assess the effect of 50 g of soy-catfish-anchovy-rice (SCAR) porridge per day for 14 days on 25(OH)D, calcium, and biomolecular serum levels in patients with VDR gene polymorphisms (TaqI or FokI). The study was a parallel, open, clinical trial. A total of 43 subjects with the VDR gene polymorphisms were selected. The subjects were divided into two groups using block randomization. There were 22 subjects in the intervention group (I) who received 50 g of SCAR porridge once per day, along with dietary counseling, and 21 subjects in the control group (C) who only received dietary counseling.
Detailed Description
Tuberculosis patients that have complications (e.g., diabetes mellitus and human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS)) who live in tropical regions experience vitamin D deficiency, especially in North Sumatra, Indonesia. The presence of vitamin D receptor (VDR) polymorphism genes, TaqI and FokI, is one of the predisposing factors, as is high levels of inflammatory markers, also indicating disease progression and malnutrition. This study aims to assess the effect of 50 g of soy-catfish-anchovy-rice (SCAR) porridge per day for 14 days on 25(OH)D, calcium, and biomolecular serum levels in patients with VDR gene polymorphisms (TaqI or FokI). The study was a parallel, open, clinical trial. A total of 43 subjects with the VDR gene polymorphisms were selected. The subjects were divided into two groups using block randomization. There were 22 subjects in the intervention group (I) who received 50 g of SCAR porridge once per day, along with dietary counseling, and 21 subjects in the control group (C) who only received dietary counseling. All subjects in both groups completed the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
polymorphism, porridge, vitamin D, biomolecular

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
We aimed to determine the effect of soy, catfish, anchovy, and rice (SCAR) porridge supplementation for 14 days along with nutritional counseling on vitamin D, calcium, and biomolecular parameters on new patients diagnosed with tuberculosis and associated complications who visited two public health centers: Teladan Public Health Center and Amplas Public Health Center, located in Medan, North Sumatera, Indonesia. The sample was collected on Sumatera Island, at latitude 3.57 N and longitude 98.65 E, with enough sunlight and a temperature of ± 32 °C (90 °F). The study was performed from May to September 2019. This study was a controlled randomized clinical trial. After applying the inclusion and exclusion criteria, 43 patients participated in the study. These patients were divided into two groups: 22 patients were put into the treatment group (I) and 21 into the control group (C).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCAR Porridge Group
Arm Type
Active Comparator
Arm Description
There were 22 subjects in the intervention group (I) who received 50 g of SCAR porridge once per day, along with dietary counseling.
Arm Title
Counseling Group
Arm Type
Active Comparator
Arm Description
21 subjects in the control group (C) who only received dietary counseling
Intervention Type
Dietary Supplement
Intervention Name(s)
SCAR Porridge
Intervention Description
The treatment group was given SCAR porridge supplementation in the form of a soft porridge (a mixture of 50 g dry powder porridge added to 200 mL of hot water) along with nutritional counseling. The control group only received nutritional counseling and no SCAR porridge supplementation. A 50 g portion of SCAR porridge was provided once a day for 14 days. The SCAR porridge was monitored and administered by a researcher once a week to inquire about adherence to the supplementation consumption and perceived side effects. All research subjects went through a clearance period of one week and were requested not to consume any supplements.
Intervention Type
Other
Intervention Name(s)
Counseling
Intervention Description
21 subjects in the control group (C) who only received dietary counseling
Primary Outcome Measure Information:
Title
Vitamin D
Description
25(OH)D Serum level
Time Frame
up to 2 weeks
Title
Calcium
Description
Calcium Serum level
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
albumin
Description
albumin serum level
Time Frame
up to 2 weeks
Title
Hs CRP
Description
Hs CRP serum level
Time Frame
up to 2 weeks
Title
blood glucose
Description
blood glucose serum level
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants which have newly diagnosed with lung tuberculosis with an acid fast bacilli (AFB) result (+), aged 18-60 years, with a heterozygote genotype test performed on one of the genes TaqI and FokI, willing to participate in the study, and provided informed consent Exclusion Criteria: Participants which being pregnant and/or a breastfeeding mother
Facility Information:
Facility Name
Faculty of Medicine Universitas Sumatera Utara
City
Medan
State/Province
North Sumatra
ZIP/Postal Code
20155
Country
Indonesia

12. IPD Sharing Statement

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Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications

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