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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04613258
• Other study ID #: USU
• Status: Completed
• Phase: N/A
• Start date: May 11, 2019
• Est. completion date: September 17, 2019

Study information

• Verified date: October 2020
• Source: Universitas Sumatera Utara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: September 17, 2019
• Est. primary completion date: August 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Dietary Supplement:
• SCAR Porridge
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.

Other:
• Counseling
21 subjects in the control group (C) who only received dietary counseling

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine Universitas Sumatera Utara	Medan	North Sumatra

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D	25(OH)D Serum level	up to 2 weeks
Primary	Calcium	Calcium Serum level	up to 2 weeks
Secondary	albumin	albumin serum level	up to 2 weeks
Secondary	Hs CRP	Hs CRP serum level	up to 2 weeks
Secondary	blood glucose	blood glucose serum level	up to 2 weeks