Maintenance Dosing of Vitamin D in Crohn's Disease

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Crohns Disease, Vitamin D Deficiency

In brief

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.

Key facts

Study ID

NCT03615378

Run by

Cedars-Sinai Medical Center

People needed

10

Starts

2018-08-30

Expected to finish

2018-11-30

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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