Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT04613258
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2020-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications
Sponsor:
Universitas Sumatera Utara
Organization:
Study Overview
Official Title:
Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: