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

Primary Purpose

Roux-en-Y Gastric Bypass, Hyperparathyroidism, Secondary

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Calcium Carbonate
Calcium Citrate
Placebo
Roux-en-Y gastric bypass
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Roux-en-Y Gastric Bypass

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Enodocrinology and Internal Medicine, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Calcium Carbonate

Calcium Citrate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Parathyroid Hormone

Secondary Outcome Measures

Se-ion-calcium
P-magnesium
P-phosphate
P-25-OH-vitamin D
P-calcitriol
P-24,25-(OH)2-vitamin D
Vitamin D binding protein
Procollagen type 1 N-terminal propeptide (P1NP)
P-bone specific alkaline phosphatase
Cross-linked C-telopeptide (CTX)
24h U-calcium
24h U-phosphate

Full Information

First Posted
July 6, 2016
Last Updated
June 23, 2017
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02830789
Brief Title
Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass
Official Title
Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass in Order to Treat Secondary Hyperparathyroidism: A Clinical Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Roux-en-Y Gastric Bypass, Hyperparathyroidism, Secondary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium Carbonate
Arm Type
Experimental
Arm Description
1 tablet Unikalk Forte + 1 placebo tablet by mouth three times daily equal to 1200 mg elementary calcium and 57 µg Vitamin D3
Arm Title
Calcium Citrate
Arm Type
Experimental
Arm Description
2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Carbonate
Other Intervention Name(s)
Unikalk Forte
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium Citrate
Other Intervention Name(s)
Unikalk Citrat
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Tablet manufactured to mimic a calcium carbonate tablet
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass
Intervention Description
Roux-en-Y gastric bypass surgery at least 12 months before study inclusion
Primary Outcome Measure Information:
Title
Parathyroid Hormone
Time Frame
Change from baseline at 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Se-ion-calcium
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
P-magnesium
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
P-phosphate
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
P-25-OH-vitamin D
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
P-calcitriol
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
P-24,25-(OH)2-vitamin D
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
Vitamin D binding protein
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
Procollagen type 1 N-terminal propeptide (P1NP)
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
P-bone specific alkaline phosphatase
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
Cross-linked C-telopeptide (CTX)
Time Frame
Change from baseline at 6 weeks and 12 weeks
Title
24h U-calcium
Time Frame
Change from baseline at 12 weeks
Title
24h U-phosphate
Time Frame
Change from baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Enodocrinology and Internal Medicine, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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