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Trial record 84 of 109 for:    CALCIUM CATION

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

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

Tracking Information
First Submitted Date  ICMJE July 6, 2016
First Posted Date  ICMJE July 13, 2016
Last Update Posted Date June 26, 2017
Study Start Date  ICMJE December 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2016)
Parathyroid Hormone [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02830789 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Roux-en-Y Gastric Bypass
  • Hyperparathyroidism, Secondary
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2016)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02830789
Other Study ID Numbers  ICMJE 20160610
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lene Ring Madsen, University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Aarhus
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP