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

NCT04308850 | Unknown Early Phase 1

• 1 other identifier: SAHoWMU-CR2020-01-104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aims:Prospectively observe the effects of Vitamin D drops supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Vitamin D drops on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Exploring the relationship between Fok I gene polymorphism and the efficacy of vitamin D supplementation. 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 Fok I gene polymorphism in all participants.One group is given Vitamin D drops 400IU per day orally, and the control group do not intervene. Participants' disease activity is assessed at baseline and related indicators are determined. The disease activity is re-evaluated at 2, 6, 14, 22, 30, and 38 weeks, and the serum indexes are re-evaluated.Investigators use statistical methods to analyze whether Vitamin D drops supplementation treatment can increase the serum 25 (OH) D level of CD participants who are treated with infliximab, improve the condition of CD participants,relationship with Fok I gene polymorphism，and analyze the effects of Vitamin D drops on participants with CD is affected by factors such as disease site, disease activity, and treatment.

Conditions

Crohn's Disease; Vitamin D Deficiency; Vitamin D Supplement

Outcome Measures

Primary Outcomes (2)

• Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants

  Genotype frequency of vitamin D receptor single nucleotide polymorphisms in participants can reflect whether it is related to the severity of the disease and how much relevance.

  9month

• 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.

  9month

Secondary Outcomes (3)

• Blood calcium and phosphorus level

  9month

• erythrocyte sedimentation rate

  9month

• Concentration of C-reactive protein in participants

  9month

Study Arms (2)

Vitamin D drops

EXPERIMENTAL

This group of patients are going to supplemented with Vitamin D drops 400IU / d orally.

Drug: Vitamin D drops

Control

NO INTERVENTION

The other group do not interfere.

Interventions

Vitamin D drops DRUG

Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.

Vitamin D drops

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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
• Receiving infliximab treatment

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Crohn Disease; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Xia sheng long, Master

  Second Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia sheng long, Master

CONTACT

0086-15868532956; xsl1989@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 24, 2020
• First Posted: March 16, 2020
• Study Start: October 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

CN (1)