NCT04134065

Brief Summary

To evaluate the efficacy and safety of 12-week goal-directed therapy in the treatment of refractory inflammatory patients, and to initially explore treatment options. Patients with potential risk factors for recurrence after surgery for Crohn's disease and a serum 25(OH)D concentration \<75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100-125 nmol/L.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2019

Shorter than P25 for early_phase_1

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 17, 2019

Last Update Submit

October 18, 2019

Conditions

Vitamin D DeficiencyCrohn Disease

Keywords

Vitamin DCrohn Diseaserecurrence

Outcome Measures

Primary Outcomes (5)

  • Clinical disease activity

    CDAI score

    up to one year

  • Fecal calprotectin

    Calprotectin is a calcium-containing protein derived from neutrophils and macrophages. Its expression is tissue or cell specific and can be used as a marker for activation of acute inflammatory cells.

    up to one year

  • C-reactive protein

    circulating inflammatory markers

    up to one year

  • Discomportant complaint

    Incidence of Treatment Adverse Events

    up to one year

  • 24-hour urinary calcium

    Determination of calcium in urine for 24 hours

    up to one year

Study Arms (2)

Control group

PLACEBO COMPARATOR

The physical properties such as appearance, size, color, dosage form, weight, taste and odor of placebo should be as much as possible as the test drug, but should not contain the Vitamin D (such as tablets containing lactose).

Drug: Placebo oral capsule

Vitamin D group

EXPERIMENTAL

Liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL)

Drug: Vitamin D

Interventions

Vitamin DDRUG

patients with refractory Crohn disease and a serum 25(OH)D concentration \<75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100e125 nmol/L.

Also known as: VD
Vitamin D group
Placebo oral capsuleDRUG

the capsule contain nothing

Also known as: Placebo
Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of Crohn's Disease
  • Must be able to swallow tablets
  • Have certain factors increase the risk of surgery in CD. include:
  • current smoking
  • fistulizing and stricturing disease behaviour
  • early steroid use (medical need for steroids for treatment of first flare)
  • disease in the end of the small bowel (i.e. ileum)
  • disease in the middle part of the small bowel (i.e. jejunum), and
  • young age at the time of the diagnosis.

You may not qualify if:

  • Other serious gastrointestinal diseases
  • pregnancy
  • hypercalcemia
  • hyperparathyroidism
  • chronic kidney disease and cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Garg M, Rosella O, Rosella G, Wu Y, Lubel JS, Gibson PR. Evaluation of a 12-week targeted vitamin D supplementation regimen in patients with active inflammatory bowel disease. Clin Nutr. 2018 Aug;37(4):1375-1382. doi: 10.1016/j.clnu.2017.06.011. Epub 2017 Jun 15.

    PMID: 28651829BACKGROUND

MeSH Terms

Conditions

Vitamin D DeficiencyCrohn DiseaseRecurrence

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesInflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Yousheng Li, Doctor

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    STUDY CHAIR

Central Study Contacts

Lei Zheng, doctor

CONTACT

86-13705270060blanch_zll@hotmail.com

Lei Zheng, doctor

CONTACT

86-137-5260060blanch_zll@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

December 1, 2019

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share