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

NCT04613258 | Completed DMC

• 1 other identifier: USU
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis

Keywords

polymorphism; porridge; vitamin D; biomolecular

Outcome Measures

Primary Outcomes (2)

• Vitamin D

  25(OH)D Serum level

  up to 2 weeks

• Calcium

  Calcium Serum level

  up to 2 weeks

Secondary Outcomes (3)

• albumin

  up to 2 weeks

• Hs CRP

  up to 2 weeks

• blood glucose

  up to 2 weeks

Study Arms (2)

SCAR Porridge Group

ACTIVE COMPARATOR

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

Counseling Group

ACTIVE COMPARATOR

21 subjects in the control group (C) who only received dietary counseling

Other: Counseling

Interventions

SCAR Porridge DIETARY_SUPPLEMENT

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.

SCAR Porridge Group

Counseling OTHER

21 subjects in the control group (C) who only received dietary counseling

Counseling Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participants which being pregnant and/or a breastfeeding mother

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatra, 20155, Indonesia

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

Counseling

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: November 3, 2020
• Study Start: May 11, 2019
• Primary Completion: August 17, 2019
• Study Completion: September 17, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

ID (1)