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

• ClinicalTrials.gov Identifier: NCT02830789
• Recruitment Status: Completed
• First Posted: July 13, 2016
• Last Update Posted: June 26, 2017
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): Lene Ring Madsen, University of Aarhus

Tracking Information

• First Submitted Date: July 6, 2016
• First Posted Date: July 13, 2016
• Last Update Posted Date: June 26, 2017
• Study Start Date: December 2016
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 8, 2016): Parathyroid Hormone [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02830789 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 8, 2016)

• Se-ion-calcium [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
• P-magnesium [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
• P-phosphate [ Time Frame: 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 ]
• P-calcitriol [ Time Frame: 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 ]
• Vitamin D binding protein [ Time Frame: 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 ]
• P-bone specific alkaline phosphatase [ Time Frame: 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 ]
• 24h U-calcium [ Time Frame: Change from baseline at 12 weeks ]
• 24h U-phosphate [ Time Frame: Change from baseline at 12 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Roux-en-Y Gastric Bypass
• Hyperparathyroidism, Secondary

Intervention

• Dietary Supplement: Calcium Carbonate
  Other Name: Unikalk Forte
• Dietary Supplement: Calcium Citrate
  Other Name: Unikalk Citrat
• 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

Study Arms

• 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
  Interventions:

  • Dietary Supplement: Calcium Carbonate
  • Dietary Supplement: Placebo
  • Procedure: Roux-en-Y gastric bypass
• Experimental: Calcium Citrate
  2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3
  Interventions:

  • Dietary Supplement: Calcium Citrate
  • Procedure: Roux-en-Y gastric bypass

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 8, 2016): 38
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02830789
• Other Study ID Numbers: 20160610
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Lene Ring Madsen, University of Aarhus
• Study Sponsor: University of Aarhus
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Aarhus
• Verification Date: June 2017