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

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT02830789
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
5
Duration (Months)
7.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Calcium Carbonate
  • Dietary Supplement: Calcium Citrate
  • Dietary Supplement: Placebo
  • Procedure: Roux-en-Y gastric bypass
 N/A

Study Design

Study Type:
Interventional
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 :
Dec 1, 2016
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

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

    Dietary Supplement: Calcium Citrate
    Other Names:
  • Unikalk Citrat

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

    Outcome Measures

    Primary Outcome Measures

    1. Parathyroid Hormone [Change from baseline at 6 weeks and 12 weeks]

    Secondary Outcome Measures

    1. Se-ion-calcium [Change from baseline at 6 weeks and 12 weeks]

    2. P-magnesium [Change from baseline at 6 weeks and 12 weeks]

    3. P-phosphate [Change from baseline at 6 weeks and 12 weeks]

    4. P-25-OH-vitamin D [Change from baseline at 6 weeks and 12 weeks]

    5. P-calcitriol [Change from baseline at 6 weeks and 12 weeks]

    6. P-24,25-(OH)2-vitamin D [Change from baseline at 6 weeks and 12 weeks]

    7. Vitamin D binding protein [Change from baseline at 6 weeks and 12 weeks]

    8. Procollagen type 1 N-terminal propeptide (P1NP) [Change from baseline at 6 weeks and 12 weeks]

    9. P-bone specific alkaline phosphatase [Change from baseline at 6 weeks and 12 weeks]

    10. Cross-linked C-telopeptide (CTX) [Change from baseline at 6 weeks and 12 weeks]

    11. 24h U-calcium [Change from baseline at 12 weeks]

    12. 24h U-phosphate [Change from baseline at 12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Enodocrinology and Internal Medicine, Aarhus University Hospital Aarhus Denmark 8000

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lene Ring Madsen, PhD student, MD, University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT02830789
    Other Study ID Numbers:
    • 20160610
    First Posted:
    Jul 13, 2016
    Last Update Posted:
    Jun 26, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Hyperparathyroidism
    Hyperparathyroidism, Secondary
    Calcium, Dietary
    Calcium Carbonate
    Calcium

    Study Results

    No Results Posted as of Jun 26, 2017