NCT04276636

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

February 17, 2020

Last Update Submit

October 9, 2020

Conditions

Crohn's DiseaseVitamin D DeficiencyVitamin D Supplement

Outcome Measures

Primary Outcomes (1)

  • 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.

    1year

Secondary Outcomes (3)

  • White blood cell count

    1year

  • erythrocyte sedimentation rate

    1year

  • C-reactive protein.

    1year

Study Arms (2)

Caltrate

EXPERIMENTAL

This group of patients are going to supplemented with Caltrate 0.6 g / d orally.

Drug: Caltrate Pill

Control

NO INTERVENTION

The other group do not interfere.

Interventions

Caltrate PillDRUG

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.

Caltrate

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clearly diagnosed patients with CD
  • Vitamin D deficiency (\<= 20ng / ml)

You may not qualify if:

  • Pregnancy, lactation
  • Liver and kidney insufficiency
  • Co-morbid with other autoimmune diseases
  • Use antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes
  • Vitamin D level is normal or high

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Crohn DiseaseVitamin D Deficiency

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Xia Xia long, Master

    Second Affiliated Hospital of Wenzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia sheng long, Master

CONTACT

0086-15868532956xsl1989@foxmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

October 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations

CN(1)