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

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

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.

Study Overview

• Status: Completed
• Conditions: Roux-en-Y Gastric Bypass; Hyperparathyroidism, Secondary
• Intervention / Treatment: Dietary supplement: Calcium Carbonate; Dietary supplement: Placebo; Procedure: Roux-en-Y gastric bypass; Dietary supplement: Calcium Citrate

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Department of Enodocrinology and Internal Medicine, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: Calcium Carbonate; Other Names: Unikalk Forte; Dietary supplement: 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
Experimental: Calcium Citrate; 2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3	Procedure: Roux-en-Y gastric bypass; Roux-en-Y gastric bypass surgery at least 12 months before study inclusion; Dietary supplement: Calcium Citrate; Other Names: Unikalk Citrat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Parathyroid Hormone	Change from baseline at 6 weeks and 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium, Dietary; Calcium Carbonate
• Other Study ID Numbers: 20160610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No