Clinical trial NCT04613258: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: polymorphism
porridge
vitamin D
biomolecular
Lead sponsor: Universitas Sumatera Utara
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Vitamin D
timeFrame: up to 2 weeks
measure: Calcium
timeFrame: up to 2 weeks
Secondary outcomes:
measure: albumin
timeFrame: up to 2 weeks
measure: Hs CRP
timeFrame: up to 2 weeks
measure: blood glucose
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Medan
country: Indonesia
facility: Faculty of Medicine Universitas Sumatera Utara
state: North Sumatra
Study officials:
References: