NCT03615378

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohns Disease
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	5000 IU D3	Daily
DIETARY_SUPPLEMENT	1000 IU D3	Daily
DIETARY_SUPPLEMENT	Placebo	lactose/sugar tablet

Timeline

• Start date: 2018-08-30
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2018-08-03
• Last updated: 2019-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study