Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Ulcerative Colitis Clinical Trial

— ACTIVATED  

Official title:

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04225819
• Other study ID #: 2019P003843
• Status: Suspended
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: April 1, 2027

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources. The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission. Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Established diagnosis of CD, UC, or IBD-unspecified
• Initiating anti-TNF therapy for IBD within 2 weeks of baseline/randomization
• Other non-anti-TNF IBD medications must remain stable during the treatment period with the exception of tapering of corticosteroids.
• Recent (within 6 months) objective evidence of active IBD on colonoscopy along with elevated inflammatory markers (C-reactive protein >8 mg/L or fecal calprotectin >150 mcg/g)
• Current disease activity defined as a Harvey Bradshaw index > 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index > 2 at baseline (week 0) for UC subjects.
• Fecal Calprotectin level >150 mcg/g

Exclusion Criteria:

• Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
• Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
• Known intolerance or hypersensitivity to oral vitamin D3 supplementation
• Plasma 25(OH)D > 60 ng/mL
• Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
• Serum calcium >11 mg/dL
• History of hyperparathyroidism
• History of renal calculi or chronic kidney disease
• Initiation of anti-TNF treatment for extra-intestinal symptoms alone
• Evidence of untreated infection (e.g. Clostridium difficile)
• History of chronic pancreatitis
• History of cystic fibrosis
• History of gastric bypass
• Presence of stoma or J-pouch

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• IBD
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis
• Vitamin D3 Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water

Other:
• Placebo
Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome	Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.	14 weeks
Primary	stool microbiome in IBD patients	Stool samples will be taken at baseline and week 14 to assess change in stool microbiome	14 weeks
Primary	serum cathelicidin levels	Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels	14 weeks
Primary	HBI	Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14	14 weeks
Primary	SCCAI	Patients with Ulcerative Colitis will complete the Simple Clinical Colitis Activity Index questionnaire to measure disease activity at baseline, week 6 and week 14	14 weeks
Secondary	fecal calprotectin	Stool samples will be taken at baseline and week 14 to assess change in fecal calprotectin levels	14 weeks
Secondary	plasma 25(OH)D levels.	Plasma samples will be taken at baseline and week 14 to measure 25(OH)D levels	14 weeks