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 - 80 Years|
- - Ulcerative colitis with confirmed diagnosis by histology and endoscopy AND in stable remission for 3 months or more without therapy or with maintenance therapy (except steroids and antibiotics for 3 months) OR having a mild disease.
- - A negative pregnancy test.
- - No history or diagnosis of any of the following conditions: Crohn's disease, bleeding disorders, gastrointestinal or colonic malignancy, Kidney disease, including kidney "stones" or hypercalcemia, Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin.
- - Ingested certain medications (Calcium, Vitamin D, fiber supplements and Non-steroidal anti-inflammatory drugs - NSAIDs) within 30 days of study start.
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|James VaraniMuhammad N Aslam|
|Principal Investigator Affiliation||University of MichiganUniversity of Michigan|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
To be taken for 180 days
Placebo Comparator: Placebo first then Aquamin®
Placebo: To be taken for the first 90 days. Aquamin®: To be taken for the last 90 days (after crossover)
Drug: - Aquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)
Drug: - Placebo first then Aquamin®
4 capsules per day; 2 to be taken in the morning and 2 in the evening
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.