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

A Retrospective Analysis on the Influence of Caltrate Supplement on the Clinical 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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Ulcerative Colitis; Vitamin D Supplement
• Intervention / Treatment: Drug: Caltrate

Detailed Description

1. The research has been approved by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University.
2. 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.
3. Assess disease activity of UC participants based on the "Mayo score".
4. General information about participants with UC is collected.
5. Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin, creatinine, calcium and phosphorus levels are measured.
6. The level of serum 25 (OH) D of participants is detected.
7. Participants are divided into two groups, one group was given oral Caltrate 0.6g/d +Mesalazine, and the other group only took Mesalazine .
8. The above serum indicators are re-measured in the 12th month, and the condition of UC participants is also evaluated.

9. Follow-up for 12 months. By comparing the above indicators, observe that in the Han population:

   1. Can Caltrate supplementation increase serum 25 (OH) D levels in patients with UC?
   2. Can Caltrate supplementation improve the condition of patients with UC?
   3. Whether Caltrate works synergistically with Mesalazine?
   4. whether the effect of Caltrate on UC patients is affected by factors such as disease site, disease activity, treatment, etc ..
10. 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.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • SAHWenzhouMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Caltrate+Mesalazine; Patients in this group were received with Caltrate 0.6 g/d and Mesalazine 4g/d orally at least 12 months.	Drug: Caltrate; 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.
Mesalazine; Patients in this group were received with Mesalazine 4g/d orally at least 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum 25 (OH) D level	Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.	12 months
Mayo score		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
erythrocyte sedimentation rate	ESR can be used to reflect the degree of inflammation in the body.	12 months
C-reactive protein	C-reactive protein can be used to reflect the degree of inflammation in the human body	12 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Principal Investigator: Xia sheng long, Master, Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammatory Bowel Diseases; Ulcer; Vitamin D Deficiency; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: SAHoWMU-CR2020-01-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No