Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
NCT ID: NCT05854342
Last Updated: 2023-05-11
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
NA
120 participants
INTERVENTIONAL
2021-06-01
2022-04-01
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
PREVENTION
DOUBLE
Study Groups
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bicarbonate-calcium water
participants of this group drink bicarbonate-calcium water
bicarbonate-calcium water
water with high content of bicarbonate and calcium, low sodium
low mineral water
participants of this group drink low mineral water
No interventions assigned to this group
Interventions
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bicarbonate-calcium water
water with high content of bicarbonate and calcium, low sodium
Eligibility Criteria
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Inclusion Criteria
* Menopausal women, period of early menopause 1-10 years
Exclusion Criteria
* estrogen-replacement hormone therapy
* osteoporosis therapy
* corticosteroid therapy
* insulin therapy.
* calcium supplementation
* kidney diseases of medium-severe level
* liver diseases of medium-severe level
* severe osteoporosis
FEMALE
Yes
Sponsors
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San Giuseppe Moscati Hospital
OTHER
University of Salerno
OTHER
Responsible Party
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Luca Rastrelli
Principal Investigator Full Professor Luca Rastrelli
Locations
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University of Salerno
Salerno, , Italy
Countries
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References
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Meunier PJ, Jenvrin C, Munoz F, de la Gueronniere V, Garnero P, Menz M. Consumption of a high calcium mineral water lowers biochemical indices of bone remodeling in postmenopausal women with low calcium intake. Osteoporos Int. 2005 Oct;16(10):1203-9. doi: 10.1007/s00198-004-1828-6. Epub 2005 Mar 3.
Wynn E, Krieg MA, Aeschlimann JM, Burckhardt P. Alkaline mineral water lowers bone resorption even in calcium sufficiency: alkaline mineral water and bone metabolism. Bone. 2009 Jan;44(1):120-4. doi: 10.1016/j.bone.2008.09.007. Epub 2008 Sep 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CECN/1522
Identifier Type: -
Identifier Source: org_study_id
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