Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass

Hyperparathyroidism, Secondary Clinical Trial

Official title:

Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass in Order to Treat Secondary Hyperparathyroidism: A Clinical Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830789
• Other study ID #: 20160610
• Status: Completed
• Phase: N/A
• First received: July 6, 2016
• Last updated: June 23, 2017
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether calcium citrate or calcium carbonate are the optimal supplement to treat secondary hyperparathyroidism following Roux-en-Y gastric bypass operation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Roux-en-Y gastric bypass operation =12 months ago

• Parathyroid hormone > 6.9 pmol/l

• Vitamin D > 50 nmol/l

• P-Calcium [1.18-1.32] mmol/l

Exclusion Criteria:

• Liver disease

• 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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Roux-en-Y Gastric Bypass

Intervention

Dietary Supplement:
• Calcium Carbonate

• Calcium Citrate

• Placebo
Tablet manufactured to mimic a calcium carbonate tablet

Procedure:
• Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery at least 12 months before study inclusion

Locations

Country	Name	City	State
Denmark	Department of Enodocrinology and Internal Medicine, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parathyroid Hormone		Change from baseline at 6 weeks and 12 weeks
Secondary	Se-ion-calcium		Change from baseline at 6 weeks and 12 weeks
Secondary	P-magnesium		Change from baseline at 6 weeks and 12 weeks
Secondary	P-phosphate		Change from baseline at 6 weeks and 12 weeks
Secondary	P-25-OH-vitamin D		Change from baseline at 6 weeks and 12 weeks
Secondary	P-calcitriol		Change from baseline at 6 weeks and 12 weeks
Secondary	P-24,25-(OH)2-vitamin D		Change from baseline at 6 weeks and 12 weeks
Secondary	Vitamin D binding protein		Change from baseline at 6 weeks and 12 weeks
Secondary	Procollagen type 1 N-terminal propeptide (P1NP)		Change from baseline at 6 weeks and 12 weeks
Secondary	P-bone specific alkaline phosphatase		Change from baseline at 6 weeks and 12 weeks
Secondary	Cross-linked C-telopeptide (CTX)		Change from baseline at 6 weeks and 12 weeks
Secondary	24h U-calcium		Change from baseline at 12 weeks
Secondary	24h U-phosphate		Change from baseline at 12 weeks