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COMPLETED
NCT07656233
NA

Effect of Isoflavone and Vitamin D Supplementation on Serum Vitamin D Levels, Body Composition, Inflammatory Markers, and Quality of Life in Patients With Inflammatory Bowel Disease

Sponsor: Indonesia University

View on ClinicalTrials.gov

Summary

Inflammatory bowel disease (IBD) is a chronic immune-mediated disorder characterized by recurrent intestinal inflammation, impaired nutritional status, and reduced quality of life. Nutritional deficiencies and alterations in body composition are frequently observed in patients with IBD and may contribute to disease burden and long-term complications. Isoflavones derived from fermented soy products, such as tempeh, have demonstrated anti-inflammatory properties in both experimental and clinical studies. Vitamin D is an important immunomodulatory nutrient, and its deficiency is common in patients with IBD. However, evidence regarding the combined effects of isoflavone and vitamin D supplementation on inflammatory markers, nutritional status, and quality of life in patients with IBD remains limited. This study aimed to evaluate the effects of daily tempeh powder supplementation providing approximately 50 mg of isoflavones and 4000 IU of vitamin D3 for 8 weeks in patients with IBD. Outcomes include changes in serum vitamin D concentration, body composition parameters, serum tumor necrosis factor-alpha (TNF-α), interleukin-10 (IL-10), and quality of life assessed using the Inflammatory Bowel Disease Questionnaire-9 (IBDQ-9).

Official title: Effect of Isoflavone and Vitamin D Supplementation on Serum Vitamin D Levels, Body Composition, Inflammatory Markers, and Quality of Life in Patients With Inflammatory Bowel Disease: An Open-Label Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-11-17

Completion Date

2026-02-25

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

OTHER

Standard medical treatment

Participants do not receive tempeh powder of isoflavone and vitamin D. They receive standard medical therapy of IBD

DIETARY_SUPPLEMENT

Tempeh Isoflavone

Participants receive 50 gram/day of tempeh powder providing approximately 50 mg of isoflavones, administered orally for 8 weeks in addition to standard medical therapy.

DIETARY_SUPPLEMENT

Vitamin D (Cholecalciferol )

Participants receive oral supplementation of vitamin D3 4000 IU/day , administered orally for 8 weeks in addition to standard medical therapy.

Locations (1)

Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia