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

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Other: Counseling; Dietary Supplement: SCAR Porridge

• Registration Number: NCT04613258
• Lead Sponsor: Universitas Sumatera Utara

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.

Study Timeline

• Study Start: 2019-05-11
• Primary Completion: 2019-08-17
• Study Completion: 2019-09-17
• Study First Submitted: 2020-09-29
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-11-03
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

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Exclusion Criteria

• Participants which being pregnant and/or a breastfeeding mother

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Counseling Group	Counseling	21 subjects in the control group (C) who only received dietary counseling
SCAR Porridge Group	SCAR Porridge	There were 22 subjects in the intervention group (I) who received 50 g of SCAR porridge once per day, along with dietary counseling.

Primary Outcome Measures

Name	Time	Method
Vitamin D	up to 2 weeks	25(OH)D Serum level
Calcium	up to 2 weeks	Calcium Serum level

Secondary Outcome Measures

Name	Time	Method
albumin	up to 2 weeks	albumin serum level
Hs CRP	up to 2 weeks	Hs CRP serum level
blood glucose	up to 2 weeks	blood glucose serum level

Trial Locations

Locations (1)

Faculty of Medicine Universitas Sumatera Utara; 🇮🇩 Medan, North Sumatra, Indonesia