NCT03615378

Maintenance Dosing of Vitamin D in Crohn's Disease

Terminated EARLY_PHASE1 Last updated 24 July 2019

What this trial tests

EARLY_PHASE1 trial testing 5000 IU D3 in Crohns Disease in 10 participants. Terminated before completion.

Timeline

30 August 2018

Primary endpoint
30 November 2018

30 November 2018

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	10
Start date	30 August 2018
Primary completion	30 November 2018
Estimated completion	30 November 2018
Sites	1 location across United States

Drugs / interventions tested

• 5000 IU D3
• 1000 IU D3
• Placebo

Conditions studied

• Crohns Disease — all drugs for Crohns Disease →
• Vitamin D Deficiency — all drugs for Vitamin D Deficiency →

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, any sex, with Crohns Disease or Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bile Salt Hydrolase-Competent Probiotics in the Management of IBD: Unlocking the "Bile Acid Code".
   Gadaleta RM, Cariello M, Crudele L, Moschetta A. · · 2022 · cited 39× · PMID 35956388 · DOI 10.3390/nu14153212
2. Modulation of the immunity and inflammation by autophagy.
   Gan T, Qu S, Zhang H, Zhou XJ. · · 2023 · cited 27× · PMID 37405276 · DOI 10.1002/mco2.311