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the Effect of Vitamin D in Crohn's Disease

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ClinicalTrials.gov Identifier: NCT04134065
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Information provided by (Responsible Party):
Lei Zheng, Nanjing University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Crohn Disease Drug: Vitamin D Drug: Placebo oral capsule Early Phase 1

Detailed Description:

The patients received oral liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL). A target 25(OH)D of 100-125 nmol/L was planned and the dose titrated 4-weekly.

Patients were evaluated at week 0 (screening visit), then 2- weekly until week 12, and at a follow-up visit at week 16. Key study endpoints were change in total 25(OH)D and attainment of level of 100e125 nmol/L. Intestinal inflammation was assessed via clinical disease activity (CDAI), faecal calprotectin (Calprotectin ELISA, Buhlmann, Basel, Switzerland), and circulating inflammatory markers (platelet count, serum albumin and C- reactive protein). Safety was assessed by direct questioning and 24- h urinary calcium excretion . Compliance was checked by dosing diaries completed by patients and measuring remaining cholecalciferol in bottles of the study drug.

Statistical analyses were performed using SPSS v20 (IBM Corporation, 2011) and GraphPad Prism v5.04 (Graphpad software, 2010). Dependent and independent samples t-tests, analysis of variance (ANOVA) and KruskaleWallis tests were used where appropriate. Associations with rise in 25(OH)D were examined by bivariate correlations. A p-value of 0.05 was considered statistically significant.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: the Effect of Target-oriented Vitamin D Treatment in Refractory Crohn's Disease
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Placebo Comparator: Control group
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
the capsule contain nothing
Other Name: Placebo

Experimental: Vitamin D group
Liquid cholecalciferol supplementation (OsteVit DTM, Key Pharmaceuticals, Macquarie Park, NSW, Australia), supplied in 50 mL bottles (5000 units in 1 mL)
Drug: Vitamin D
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.
Other Name: VD




Primary Outcome Measures :
  1. Clinical disease activity [ Time Frame: up to one year ]
    CDAI score

  2. Fecal calprotectin [ Time Frame: up to one year ]
    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.

  3. C-reactive protein [ Time Frame: up to one year ]
    circulating inflammatory markers

  4. Discomportant complaint [ Time Frame: up to one year ]
    Incidence of Treatment Adverse Events

  5. 24-hour urinary calcium [ Time Frame: up to one year ]
    Determination of calcium in urine for 24 hours



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of Crohn's Disease
  2. Must be able to swallow tablets
  3. 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.

Exclusion Criteria:

  1. Other serious gastrointestinal diseases
  2. pregnancy
  3. hypercalcemia
  4. hyperparathyroidism
  5. chronic kidney disease and cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134065


Contacts
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Contact: Lei Zheng, doctor 86-13705270060 blanch_zll@hotmail.com
Contact: Lei Zheng, doctor 86-137-5260060 blanch_zll@hotmail.com

Sponsors and Collaborators
Nanjing University School of Medicine
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Chair: Yousheng Li, Doctor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications:
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Responsible Party: Lei Zheng, Clinical Professor, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT04134065     History of Changes
Other Study ID Numbers: SJUSM
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lei Zheng, Nanjing University School of Medicine:
Vitamin D
Crohn Disease
recurrence
Additional relevant MeSH terms:
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Crohn Disease
Vitamin D Deficiency
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents