Maintenance Dosing of Vitamin D in Crohn's Disease

Early Phase 1TerminatedNCT03615378

Cedars-Sinai Medical Center10 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Crohns Disease Vitamin D Deficiency

Interventions

5000 IU D3DIETARY_SUPPLEMENT

Daily

1000 IU D3DIETARY_SUPPLEMENT

Daily

PlaceboDIETARY_SUPPLEMENT

lactose/sugar tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cedars Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Vitamin D serum level Vitamin D sufficiency

Serum level greater than or equal to 30 ng/ml

Time frame: 22 weeks

Secondary Outcomes

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)

Time frame: 22 weeks

Data from ClinicalTrials.gov

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