Maintenance Dosing of Vitamin D in Crohn's Disease

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03615378
• Other study ID #: Pro50335
• Status: Terminated
• Phase: Early Phase 1
• Start date: August 30, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: July 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohns Disease
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• 5000 IU D3
Daily
• 1000 IU D3
Daily
• Placebo
lactose/sugar tablet

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D serum level Vitamin D sufficiency	Serum level greater than or equal to 30 ng/ml	22 weeks
Secondary	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