Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass
NCT ID: NCT02830789
Last Updated: 2017-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
38 participants
INTERVENTIONAL
2016-12-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Half of the participants will be randomized to receive calcium citrate, while the other half will receive calcium carbonate. The study will be double blinded.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial Of Paricalcitol and Cholecalciferol(Vitamin D3) in the Treatment Of Secondary Hyperparathyroidism in Patients After ROUX-EN-Y Gastric Bypass Surgery
NCT01138475
The Effect of Roux-en-Y Gastric Bypass on Bone Turnover
NCT03046147
Effects of Bile Acids and Bile Acid Sequestrants on GLP-1 Secretion After Roux-en-Y Gastric Bypass
NCT02876484
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
NCT03424239
The Metabolic Effects of Prebiotic Supplementation After Roux-en-Y Gastric Bypass Surgery
NCT03517345
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Calcium Carbonate
1 tablet Unikalk Forte + 1 placebo tablet by mouth three times daily equal to 1200 mg elementary calcium and 57 µg Vitamin D3
Calcium Carbonate
Placebo
Tablet manufactured to mimic a calcium carbonate tablet
Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery at least 12 months before study inclusion
Calcium Citrate
2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3
Calcium Citrate
Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery at least 12 months before study inclusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Calcium Carbonate
Calcium Citrate
Placebo
Tablet manufactured to mimic a calcium carbonate tablet
Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery at least 12 months before study inclusion
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Parathyroid hormone \> 6.9 pmol/l
* Vitamin D \> 50 nmol/l
* P-Calcium \[1.18-1.32\] mmol/l
Exclusion Criteria
* Renal disease
* Hypercalcemia
* Untreated thyroid disease
* Parathyroid disease except secondary hyperparathyroidism
* Use of diuretics, bisphosphonates, calcitonin, teriparatide, oral corticosteroids, anabolic steroids, calcimimetics, lithium, strontium, denosumab or anticonvulsants within 1 year of inclusion
* abusing alcohol
20 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Lene Ring Madsen
PhD student, MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Enodocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20160610
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.