Clinical Trial to Evaluate the Tolerability and Efficacy of Microencapsulated Calcium Carbonate
NCT ID: NCT03452696
Last Updated: 2019-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
208 participants
INTERVENTIONAL
2018-06-15
2019-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Calcium supplement 10/90
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
Calcium supplement for low contribution of elemental calcium in the daily diet
Calcium supplement 5/95
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 supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
Calcium carbonate supplement
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 supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
Calcium citrate supplement
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
Calcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
Interventions
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Calcium supplement
Calcium supplement for low contribution of elemental calcium in the daily diet
Eligibility Criteria
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Inclusion Criteria
* Low contribution of elemental calcium in the daily diet
Exclusion Criteria
* Renal insufficiency
* History of kidney or urinary stones
* Use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones
* Use of any other drug or experimental device during the 30 days prior to the selection
45 Years
70 Years
FEMALE
No
Sponsors
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Nexentia S.A.S.
UNKNOWN
Instituto Palacios
OTHER
Responsible Party
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Dr. Santiago Palacios
Principal Investigator
Principal Investigators
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Santiago Palacios, PI
Role: PRINCIPAL_INVESTIGATOR
Instituto Palacios
Locations
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Instituto Palacios
Madrid, , Spain
Countries
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Other Identifiers
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CALCIMIP18
Identifier Type: -
Identifier Source: org_study_id
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