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

University of Aarhus

Status: Completed

Conditions: Hyperparathyroidism, Secondary; Roux-en-Y Gastric Bypass

Treatments: Dietary Supplement: Calcium Carbonate; Procedure: Roux-en-Y gastric bypass; Dietary Supplement: Calcium Citrate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02830789

20160610

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Calcium Carbonate

Experimental group

Description:

1 tablet Unikalk Forte + 1 placebo tablet by mouth three times daily equal to 1200 mg elementary calcium and 57 µg Vitamin D3

Treatment:

Dietary Supplement: Placebo

Procedure: Roux-en-Y gastric bypass

Dietary Supplement: Calcium Carbonate

Calcium Citrate

Experimental group

Description:

2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3

Treatment:

Procedure: Roux-en-Y gastric bypass

Dietary Supplement: Calcium Citrate