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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

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.


Condition or disease Intervention/treatment Phase
Roux-en-Y Gastric Bypass Hyperparathyroidism, Secondary Dietary Supplement: Calcium Carbonate Dietary Supplement: Calcium Citrate Dietary Supplement: Placebo Procedure: Roux-en-Y gastric bypass Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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 Name: 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
Dietary Supplement: Calcium Citrate
Other Name: Unikalk Citrat

Procedure: Roux-en-Y gastric bypass
Roux-en-Y gastric bypass surgery at least 12 months before study inclusion




Primary Outcome Measures :
  1. Parathyroid Hormone [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]

Secondary Outcome Measures :
  1. Se-ion-calcium [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  2. P-magnesium [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  3. P-phosphate [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  4. P-25-OH-vitamin D [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  5. P-calcitriol [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  6. P-24,25-(OH)2-vitamin D [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  7. Vitamin D binding protein [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  8. Procollagen type 1 N-terminal propeptide (P1NP) [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  9. P-bone specific alkaline phosphatase [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  10. Cross-linked C-telopeptide (CTX) [ Time Frame: Change from baseline at 6 weeks and 12 weeks ]
  11. 24h U-calcium [ Time Frame: Change from baseline at 12 weeks ]
  12. 24h U-phosphate [ Time Frame: Change from baseline at 12 weeks ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830789


Locations
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Denmark
Department of Enodocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus

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Responsible Party: Lene Ring Madsen, PhD student, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT02830789     History of Changes
Other Study ID Numbers: 20160610
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Neoplastic Processes
Neoplasms
Pathologic Processes
Parathyroid Diseases
Endocrine System Diseases
Calcium, Dietary
Calcium Carbonate
Citric Acid
Sodium Citrate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antacids
Gastrointestinal Agents