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Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency

NCT04276636 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-14

No results posted yet for this study

Summary

Aims:Prospectively observe the effects of Caltrate supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Provide a certain theoretical basis for "precision treatment" for CD patients in the future.

Design：It is a prospective cohort study. Investigators include a total of 60 participants with CD according to the inclusion and exclusion criteria, and divide them into two groups to assess their initial disease activity and detect related indicators. At the same time，Investigators detect the Vitamin D Gene gene polymorphisms in all participants.One group is given Caltrate 0.6g per day orally, and the control group do not intervene. After 12 months, re-evaluate the disease activity and retest the relevant indicators, and use statistical methods to analyze whether Caltrate supplementation treatment can increase the serum 25 (OH) D level of CD participants, improve the condition of CD participants,relationship with Vitamin D Gene Polymorphism，and analyze the effect of Caltrate on participants with CD is affected by factors such as disease site, disease activity, and treatment.

Conditions

Interventions

DRUG

Caltrate Pill

Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Caltrate Pill 0.6 g / d, while the other group do not interfere.

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Xia Xia long, Master · Second Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04276636 on ClinicalTrials.gov