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Study identifier: NCT07656233 Synced from ClinicalTrials.gov · August 03, 2026
● Completed

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

Condition: Ulcerative Colitis (UC) · Crohn Disease (CD)  ·  Sponsor: Indonesia University

PhaseNA
Planned participants50
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (1)

Dr. Cipto Mangunkusumo Hospital, Jakarta, IndonesiaJakarta Pusat, DKI Jakarta, Indonesia

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