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

NCT04276649 | Completed

• 1 other identifier: SAHoWMU-CR2020-01-103
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis; Vitamin D Deficiency; Vitamin D Supplement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• erythrocyte sedimentation rate

  12 months

• C-reactive protein

  12 months

Study Arms (2)

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

Mesalazine

Patients in this group were received with Mesalazine 4g/d orally at least 12 months.

Interventions

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.

Caltrate+Mesalazine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Vitamin D Deficiency

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Xia sheng long, Master

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: January 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Locations

CN (1)