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NCT Number: NCT02830789

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

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.

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Key information

Conditions

Roux-en-y Gastric Bypass Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Enodocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium Carbonate

Dietary Supplement

Other names: Unikalk Forte

calcium citrate

Dietary Supplement

Other names: Unikalk Citrat

Placebo

Dietary Supplement

Tablet manufactured to mimic a calcium carbonate tablet

Roux-en-Y gastric bypass

Procedure

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

Primary outcomes

  1. Parathyroid Hormone

    Time frame: Change from baseline at 6 weeks and 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Investigation of the Optimal Calcium Supplement Following Roux-en-Y Gastric Bypass in Order to Treat Secondary Hyperparathyroidism: A Clinical Randomized Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2016
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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