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

• Sponsor: Universitas Sumatera Utara (Other)
• Overall Status: Completed
• CT.gov ID: NCT04613258
• Collaborator: (none)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Dietary Supplement: SCAR Porridge; Other: Counseling	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• 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).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)
• Primary Purpose: Diagnostic
• Official Title: Soy, Catfish, Anchovy, and Rice Supplementation Increases 25(OH)D Serum Levels in Tuberculosis Patients With Complications
• Actual Study Start Date: May 11, 2019
• Actual Primary Completion Date: Aug 17, 2019
• Actual Study Completion Date: Sep 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SCAR Porridge Group There were 22 subjects in the intervention group (I) who received 50 g of SCAR porridge once per day, along with dietary counseling.	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.
Active Comparator: Counseling Group 21 subjects in the control group (C) who only received dietary counseling	Other: Counseling; 21 subjects in the control group (C) who only received dietary counseling

Outcome Measures

Primary Outcome Measures

1. Vitamin D [up to 2 weeks]

   25(OH)D Serum level

2. Calcium [up to 2 weeks]

   Calcium Serum level

Secondary Outcome Measures

1. albumin [up to 2 weeks]

   albumin serum level

2. Hs CRP [up to 2 weeks]

   Hs CRP serum level

3. blood glucose [up to 2 weeks]

   blood glucose serum level

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Universitas Sumatera Utara	Medan	North Sumatra	Indonesia	20155

Sponsors and Collaborators

• Universitas Sumatera Utara

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - May 12, 2020
• Study Protocol and Statistical Analysis Plan - May 16, 2020

More Information

Publications

None provided.

• Responsible Party: DINA KEUMALA SARI, Principal Investigator, Universitas Sumatera Utara
• ClinicalTrials.gov Identifier: NCT04613258
• Other Study ID Numbers: USU
• First Posted: Nov 3, 2020
• Last Update Posted: Nov 3, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by DINA KEUMALA SARI, Principal Investigator, Universitas Sumatera Utara: polymorphism; porridge; vitamin D; biomolecular
• Additional relevant MeSH terms: Tuberculosis

Study Results

No Results Posted as of Nov 3, 2020