NCT01877577

Brief Summary

This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them. Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

June 11, 2013

Last Update Submit

July 1, 2014

Conditions

Crohn's Disease (CD)Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

  • vitamin D3 supplementation in IBD patients with hypovitaminosis D.

    To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D.

    90 days after patient taking the Vitamin D3 supplement daily

Secondary Outcomes (1)

  • vitamin D3 supplementation on disease activity and quality of life

    90 days after patient taking the Vitamin D3 supplement daily

Study Arms (2)

2000 I/U Vitamin D3

ACTIVE COMPARATOR

2000 I/U Vitamin D3 Daily

Dietary Supplement: Vitamin D3

4000 I/U Vitamin D3

ACTIVE COMPARATOR

4000 I/U Vitamin D3 Daily

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Study patients who took 2,000 IU daily of vitamin D3 will be compared to those who took 4,000 IU daily to determine the different effects of vitamin D3 dose on quality of life, disease activity, and the laboratory tests in this study.

Also known as: vitamin D3 cholecalciferol
2000 I/U Vitamin D34000 I/U Vitamin D3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis)
  • years of age or older
  • (OH)D levels \<30ng/ml
  • willing to give informed written consent

You may not qualify if:

  • Age \< 18 years
  • Women who are pregnant or planning to become pregnant
  • Patients already taking vitamin D3 ≥2,000 IU/daily prior to study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Regional Medical Center, Ambulatory Care Center

Fresno, California, 93721, United States

Location

Related Publications (4)

  • Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209.

    PMID: 21677747BACKGROUND

  • Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.

    PMID: 21527593BACKGROUND

  • Kong J, Zhang Z, Musch MW, Ning G, Sun J, Hart J, Bissonnette M, Li YC. Novel role of the vitamin D receptor in maintaining the integrity of the intestinal mucosal barrier. Am J Physiol Gastrointest Liver Physiol. 2008 Jan;294(1):G208-16. doi: 10.1152/ajpgi.00398.2007. Epub 2007 Oct 25.

    PMID: 17962355BACKGROUND

  • Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.

    PMID: 21118827BACKGROUND

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • David Limsui, MD

    Assistant Clinical Professor, UCSF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 13, 2013

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

September 1, 2013

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

US(1)