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Completed

NCT Number: NCT04991324

Cholecalciferol Comedication in IBD - the 5C-study

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/ l) is associated with irritable bowel disease (IBD). National guidelines recommend the administration of 800 -4000 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly or weekly is possible. The study aims to compare inflammation activity (primary outcome) after monthly or weekly treatment with soft capsules containing 24'000 IU cholecalciferol compared to no vitamin D supplementation. Quantification of 25(OH)-vitamin D serum values is a secondary outcome. The investigators will use newly developed soft capsules.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clarunis

Basel, 4031, Switzerland

About this study

Monthly supplementation: Monthly administration of a capsule containing 24'000 IU vitamin D, corresponding to a dose of approximately 800 IU per day, as comedication to the usual treatment during 6 months.

Weekly supplementation: Weekly administration of a capsule containing 24'000 IU vitamin D, corresponding a dose of approximately 3500 IU per day, as comedication to the usual treatment during 6 months.

Control: Usual treatment without vitamin D supplementation. All 3 groups: In a follow-up phase of 6 months, all participants can choose whether they want a monthly vitamin D supplementation or not.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of Crohn disease or ulcerative colitis

Exclusion criteria

  • hypercalcaemia

Treatment and study plan

Vitamin D3

Drug

24,000 IU cholecalciferol

Other names: D3 VitaCaps

Primary outcomes

  1. fecal calprotectin

    Time frame: every 2 months during 6 months

    laboratory disease activity

Secondary outcomes

  1. (OH)-vitamin D serum value

    Time frame: every 2 months during 6 months

    serum value cholecalciferol

Other outcomes

  1. disease activity score

    Time frame: every 2 months during 6 months

    clinical disease activity

  2. medication adherence

    Time frame: every 2 months during 6 months

    adherence to vitamin D supplementation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Cholecalciferol Comedication in Patients With Chronic Inflammatory Bowel Diseases (Crohn's Disease or Ulcerative Colitis) - the 5C-study

Acronym: 5C

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2021
Registry last updated
Dec 24, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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