Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease

It is uncertain whether vitD3 supplementation is beneficial for the remission of Crohn's disease (CD). The effects of vitD3 supplements on the efficacy of ustekinumab in Chinese CD patients were retrospectively analyzed. Methods: Patients with moderate to severe CD were recorded. These patients were initially treated with UST. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of UST and continued throughout the follow-up period. Disease activity was assessed using Harvey Bradshaw Index.

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Key information

Conditions

Ustekinumab Clinical Efficacy Crohn Disease Crohn's Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Vitamin D Supplementation

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

moderate-to-severe CD
Treated with Ustekinumab

Exclusion criteria

had recent supplementation of vitD3
pregnant
had cognitive/developmental disorders that affected their ability to complete the study procedures
had medical illness or therapies potentially affecting bone, nutrition or growth status
unknown or untested baseline serum 25(OH)D level

Treatment and study plan

Primary outcomes

Serum 25 (OH) D level

Time frame: 24 weeks

Vitamin D deficiency is defined as serum 25 (OH) D level<20 μ g/L
disease activity

Time frame: 24weeks

Harvey Bradshaw Index，mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25

Secondary outcomes

Serum 25 (OH) D level

Time frame: 8 weeks

Vitamin D deficiency is defined as serum 25 (OH) D level<20 μ g/L

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: May 22, 2023
Registry last updated: May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed