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| Name | Class |
|---|---|
| Nexentia S.A.S. | UNKNOWN |
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Interventional Clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a population of postmenopausal women, lasting 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium supplement 10/90 | Experimental | Microencapsulated calcium, 1389 mg orally (10% protein and 90% calcium carbonate, corresponding to 500 mg of calcium element per tablet). There will be 2 doses of 1389 mg each orally, to make a total contribution of 1,000 mg. of calcium element. |
|
| Calcium supplement 5/95 | Experimental | Microencapsulated calcium1316 mg orally (5% protein and 95% calcium carbonate, corresponding to 500 mg of calcium element per tablet). There will be 2 shots of 1,316 mg each orally, to make a total contribution of 1,000 mg. calcium element |
|
| Calcium carbonate supplement | Active Comparator | 1,250 mg orally (500 mg of calcium element). There will be 2 doses of 1,250 mg. each orally, to make a total contribution of 1,000 mg. of calcium element. |
|
| Calcium citrate supplement | Active Comparator | 1,500 mg orally (315 mg of calcium element). There will be 2 taken orally, to make a total contribution of 945 mg. calcium element |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium supplement | Dietary Supplement | Calcium supplement for low contribution of elemental calcium in the daily diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastric symptoms | Using the Gastrointestinal Symptom Rating Scale (GRS). The scale measures constipation, diarrhea, windiness, swelling, nausea, reflux, pain and burning. The patient will have to choose the most appropriate response among those proposed. "Not at all" is the better outcome and "very strong discomfort" is the worst outcome | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bone markers | Bone Marker Analysis (CTx and P1NP) will be performed | Basal and 1 month |
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Inclusion Criteria:
Exclusion Criteria:
Only women
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Palacios, PI | Instituto Palacios | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Palacios | Madrid | 28009 | Spain |
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| ID | Term |
|---|---|
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
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Women