Maintenance Dosing of Vitamin D in Crohn's Disease

A Randomized, Double Blind, Placebo Controlled Trial Evaluating Optimal Maintenance Strategies of Vitamin D Levels in Patients With Crohn's Disease in Remission

Vitamin D repletion is important for bone health in patients with Crohn's disease. While repletion strategies in the general population yield similar results in those with Crohn's disease, maintenance strategies are variable. High quality evidence is lacking to determine the optimal strategy to maintain adequate levels of Vitamin D levels in patients with Crohn's disease.

Study Overview

• Status: Terminated
• Conditions: Vitamin D Deficiency; Crohns Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: 1000 IU D3; Dietary supplement: 5000 IU D3

Detailed Description

The investigators seek to identify patients with Crohn's disease in clinical remission who have vitamin D levels <30 ng/ml. Subjects will undergo a 8 week lead in period and receive Vitamin D supplementation with 50,000 IU D2 weekly for 8 weeks.Participants with sufficient Vitamin D levels after 8 weeks (>30 ng/mL) will be enrolled into the study and randomized to one of three arms: (1) placebo (2) 1000 IU/day Vitamin D3 (3) 5,000 IU/day Vitamin D3 for 22 weeks. Based on clinical experience, doses higher than the recommended doses for bone health in the general population (600-800 IU/day Vitamin D3) are needed to achieve and maintain optimal levels of Vitamin D in people with Crohn's disease.

The investigators aim to determine optimal maintenance dosing to sustain vitamin D sufficiency in people with Crohn's disease. The investigators also seek to determine demographic and disease related characteristics associated with inability to maintain sufficient levels.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of Crohn's disease
2. In clinical remission as determined by the Harvey Bradshaw Index (CD) ≤4
3. 25(OH)D level <30 ng/ml within three months of study enrollment
4. Prior 25(OH)D level <30 ng/ml currently on repletion therapy
5. Provided written informed consent
6. 18 years of age or older
7. All maintenance therapies required to be on stable doses for 3 months.

Exclusion Criteria:

1. Unwilling to provide consent or lack capacity
2. Clinical disease activity (Harvey Bradshaw index >4)
3. Current pregnancy or attempting to conceive
4. Hypercalcemia (must have calcium level within 6 months of enrollment)
5. Known coexisting hyperparathyroidism
6. BMI >30 kg/m²
7. History of kidney stones
8. Subjects <18 years of age - pediatric population with different recommended dosing than adults
9. Non-english speakers
10. Has an ileo-anal pouch or ileostomy
11. C-reactive protein greater than 2x the upper limit of normal
12. Lactose intolerant
13. Short gut syndrome
14. Renal insufficiency (CrCl <60 ml/min)
15. Concomitant therapy with thiazide diuretics, barbiturates, digitalis or supplemental products containing vitamin D
16. Vitamin D levels <30ng/ml at completion of lead in

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; lactose/sugar tablet
ACTIVE_COMPARATOR: Vitamin D 1000 IU D3 daily	Dietary supplement: 1000 IU D3; Daily
ACTIVE_COMPARATOR: Vitamin D 5000 IU D3 daily	Dietary supplement: 5000 IU D3; Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D serum level Vitamin D sufficiency	Serum level greater than or equal to 30 ng/ml	22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Vitamin D Insufficiency	Time (in weeks) from the measurement of sufficiency (at week 0) to Vitamin D insufficiency (defined as serum vitamin D level less than 30 ng/mL)	22 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2018
• Primary Completion (ACTUAL): November 30, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (ACTUAL): August 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammatory Bowel Diseases; Vitamin D Deficiency; Crohn Disease
• Other Study ID Numbers: Pro50335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No information will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes