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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium Carbonate | Experimental | 1 tablet Unikalk Forte + 1 placebo tablet by mouth three times daily equal to 1200 mg elementary calcium and 57 µg Vitamin D3 |
|
| Calcium Citrate | Experimental | 2 tablets Unikalk Citrat by mouth three times daily equal to 1200 mg elementary calcium and 60 µg Vitamin D3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Carbonate | Dietary Supplement |
|
| |
| Calcium Citrate |
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroid Hormone | Change from baseline at 6 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Se-ion-calcium | Change from baseline at 6 weeks and 12 weeks | |
| P-magnesium | Change from baseline at 6 weeks and 12 weeks | |
| P-phosphate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Enodocrinology and Internal Medicine, Aarhus University Hospital | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D019355 | Calcium Citrate |
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Dietary Supplement |
|
|
| 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 |
|
| Change from baseline at 6 weeks and 12 weeks |
| P-25-OH-vitamin D | Change from baseline at 6 weeks and 12 weeks |
| P-calcitriol | Change from baseline at 6 weeks and 12 weeks |
| P-24,25-(OH)2-vitamin D | Change from baseline at 6 weeks and 12 weeks |
| Vitamin D binding protein | Change from baseline at 6 weeks and 12 weeks |
| Procollagen type 1 N-terminal propeptide (P1NP) | Change from baseline at 6 weeks and 12 weeks |
| P-bone specific alkaline phosphatase | Change from baseline at 6 weeks and 12 weeks |
| Cross-linked C-telopeptide (CTX) | Change from baseline at 6 weeks and 12 weeks |
| 24h U-calcium | Change from baseline at 12 weeks |
| 24h U-phosphate | Change from baseline at 12 weeks |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |