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Completed

NCT Number: NCT04276649

A Retrospective Analysis: the Influence of Caltrate Supplement on the Effect of Mesalazine in Ulcerative Colitis

Aims:Retrospectively observe the effects of Caltrate supplementation on the clinical effect of mesalazine in patients with ulcerative colitis.

Design: From January 2015 to December 2020, through retrieving the clinical database of the Second Affiliated Hospital of Wenzhou Medical University, patients with active UC who accepted mesalazine treatment were enrolled. According to whether Caltrate was supplemented at the same time, the patients were divided into supplementary group and non-supplementary group. The modified Mayo score and several laboratory indicators were compared between the two groups.

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Key information

Conditions

Ulcerative Colitis Avitaminosis Colitis Colitis, Ulcerative Colonic Diseases Deficiency Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency Vitamin D Supplement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

About this study

  • The research has been approved by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
  • According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients with clear diagnosis of UC are collected. Exclusion criteria included: history of vitamin D treatment within the previous 3 months; treated with glucocorticoids, immunosuppressants, biologic agents, or colectomy during the follow-up; severe liver and kidney dysfunction; other autoimmune diseases.
  • Assess disease activity of UC participants based on the "Mayo score".
  • General information about participants with UC is collected.
  • Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin, creatinine, calcium and phosphorus levels are measured.
  • The level of serum 25 (OH) D of participants is detected.
  • Participants are divided into two groups, one group was given oral Caltrate 0.6g/d +Mesalazine, and the other group only took Mesalazine .
  • The above serum indicators are re-measured in the 12th month, and the condition of UC participants is also evaluated.
  • Follow-up for 12 months. By comparing the above indicators, observe that in the Han population:
  • Can Caltrate supplementation increase serum 25 (OH) D levels in patients with UC?
  • Can Caltrate supplementation improve the condition of patients with UC?
  • Whether Caltrate works synergistically with Mesalazine?
  • whether the effect of Caltrate on UC patients is affected by factors such as disease site, disease activity, treatment, etc ..
  • Through statistical analysis, comprehensive analysis of the effectiveness and safety of Caltrate supplementation in Han patients with UC, providing a theoretical basis for further "precise treatment" intervention in inflammatory bowel disease.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clearly diagnosed patients with UC
  • Took mesalazine for at least 12 months

Exclusion criteria

  • had recent supplementation of vitD3
  • had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment or follow up
  • Co-morbid with other autoimmune diseases
  • Severe liver and kidney dysfunction

Treatment and study plan

Caltrate

Drug

Patients in supplementary group were received with Caltrate 0.6 g/d and Mesalazine 4g/d orally at least 12 months, and those in non-supplementary only take Mesalazine 4g/d.

Primary outcomes

  1. Serum 25 (OH) D level

    Time frame: 12 months

    Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.

  2. Mayo score

    Time frame: 12 months

Secondary outcomes

  1. erythrocyte sedimentation rate

    Time frame: 12 months

    ESR can be used to reflect the degree of inflammation in the body.

  2. C-reactive protein

    Time frame: 12 months

    C-reactive protein can be used to reflect the degree of inflammation in the human body

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

A Retrospective Analysis on the Influence of Caltrate Supplement on the Clinical Effect of Mesalazine in Ulcerative Colitis

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Feb 19, 2020
Registry last updated
Sep 14, 2021

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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