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

June 23, 2017 updated by: Lene Ring Madsen, University of Aarhus

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Change from baseline at 6 weeks and 12 weeks
Change from baseline at 6 weeks and 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 20160610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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