Maintenance Dosing of Vitamin D in Crohn's Disease

Status Terminated

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03615378
Study type	Interventional
Source	Cedars-Sinai Medical Center
Contact
Status	Terminated
Phase	Early Phase 1
Start date	August 30, 2018
Completion date	November 30, 2018

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Recruiting	`NCT05459298` - ViDES Trial (Vitamin D Extra Supplementation)	N/A
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT04476511` - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules	Phase 3
Completed	`NCT03920150` - Vitamin D 24'000 IU for Oral Intermittent Supplementation	Phase 3
Completed	`NCT03264625` - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis	Phase 2
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Recruiting	`NCT05084248` - Vitamin D Deficiency in Adults Following a Major Burn Injury	Phase 4
Completed	`NCT05506696` - Vitamin D Supplementation Study	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Completed	`NCT03234218` - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed	`NCT02714361` - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women	N/A
Completed	`NCT02906319` - Vitamin D and HbA1c Levels in Diabetic Patients With CKD	N/A
Completed	`NCT03203382` - Corneal Nerve Structure in Sjogren's
Completed	`NCT02118129` - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.	N/A
Completed	`NCT02187146` - The Effects of Serum Vitamin D and IVF Outcome	N/A
Not yet recruiting	`NCT01419821` - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5	N/A
Completed	`NCT02275650` - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter	N/A
Completed	`NCT01688102` - The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile	N/A
Completed	`NCT01741181` - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2	Phase 4