Maintenance Dosing of Vitamin D in Crohn's Disease

Early Phase 1

Terminated

• Conditions: Crohns Disease; Vitamin D Deficiency
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: 1000 IU D3; Dietary Supplement: 5000 IU D3

• Registration Number: NCT03615378
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Study Start: 2018-08-30
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vitamin D 1000 IU D3 daily	1000 IU D3	-
Vitamin D 5000 IU D3 daily	5000 IU D3	-

Primary Outcome Measures

Name	Time	Method
Vitamin D serum level Vitamin D sufficiency	22 weeks	Serum level greater than or equal to 30 ng/ml

Secondary Outcome Measures

Name	Time	Method
Time to Vitamin D Insufficiency	22 weeks	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)

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States