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

Not Applicable

Completed

• Conditions: Roux-en-Y Gastric Bypass; Hyperparathyroidism, Secondary
• Interventions: Dietary Supplement: Calcium Citrate; Dietary Supplement: Calcium Carbonate; Dietary Supplement: Placebo; Procedure: Roux-en-Y gastric bypass

• Registration Number: NCT02830789
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Study Start: 2016-12
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium Carbonate	Placebo	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	Roux-en-Y gastric bypass	1 tablet Unikalk Forte + 1 placebo tablet by mouth three times daily equal to 1200 mg elementary calcium and 57 µg Vitamin D3
Calcium Citrate	Calcium Citrate	2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3
Calcium Carbonate	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 Citrate	Roux-en-Y gastric bypass	2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3

Primary Outcome Measures

Name	Time	Method
Parathyroid Hormone	Change from baseline at 6 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Se-ion-calcium	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
24h U-calcium	Change from baseline at 12 weeks
P-magnesium	Change from baseline at 6 weeks and 12 weeks
Vitamin D binding protein	Change from baseline at 6 weeks and 12 weeks
P-bone specific alkaline phosphatase	Change from baseline at 6 weeks and 12 weeks
24h U-phosphate	Change from baseline at 12 weeks
P-phosphate	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
Procollagen type 1 N-terminal propeptide (P1NP)	Change from baseline at 6 weeks and 12 weeks
Cross-linked C-telopeptide (CTX)	Change from baseline at 6 weeks and 12 weeks

Trial Locations

Locations (1)

Department of Enodocrinology and Internal Medicine, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark