Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. VITAMIN D SCREENING STUDY Those:
- - With a confirmed diagnosis of Crohn's Disease (CD) - ≥ 18 years of age - Have provided written informed consent 2.
- - With a confirmed diagnosis of CD
- Identified as having Vitamin D deficiency < 50 nmol/L in the Winter screening study
- ≥ 18 years of age
- Already receiving treatment for CD as per National Institute for Health and Care
Excellence (NICE) Guidance or those in remission and not currently receiving treatment
but who continue to attend hospital out-patient appointments
- Have provided written informed consent
- - None 2.
- - Currently receiving vitamin D, fish oil or multi-vitamin supplementation and unwilling to stop this to participate in the feasibility trial - Currently receiving: - Bisphosphonates - Digitalis or other cardiac glycosides - Phenytoin - Barbituates (e.g. Amylobarbitone, Butobarbitone, Methyl Phenobarbitone, Pentobarbitone, Quinalbarbitone, Amylobarbitone) - Actinomycin - Imidazole - With known hyperparathyroidism - With known sarcoidosis - With known renal disease or kidney stones - With known hypercalcaemia (corrected serum calcium ≥2.60 mmol/L) - With known underlying liver disease - With known hypersensitivity to vitamin D supplements or any of the trial medication excipients - Who are pregnant, breast feeding, trying to conceive or women of child-bearing age who decline to have a pregnancy test where applicable.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University Hospital Birmingham NHS Foundation Trust|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Sheldon C Cooper, Dr|
|Principal Investigator Affiliation||Univeristy Hospital Birmingham NHS Trust|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Crohn Disease, Vitamin D Deficiency|
Active Comparator: Arm A - Cholecalciferol 400iu
Vitamin D3 (Cholecalciferol) 400 iu. Daily oral capsule. To be taken for 24 weeks (6 months)
Experimental: Arm B - Cholecalciferol 3200iu/800iu
Vitamin D3 (Cholecalciferol) supplement 3,200iu daily oral capsule. To be taken for 12 weeks (3 months). Then switch to vitamin D3 supplement 800iu daily oral capsule. To be taken for 12 weeks (3 months).
Dietary Supplement: - Cholecalciferol
vitamin D3 daily oral supplement
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.