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| Name | Class |
|---|---|
| San Giuseppe Moscati Hospital | OTHER |
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The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bicarbonate-calcium water | Experimental | participants of this group drink bicarbonate-calcium water |
|
| low mineral water | No Intervention | participants of this group drink low mineral water |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bicarbonate-calcium water | Other | water with high content of bicarbonate and calcium, low sodium |
|
| Measure | Description | Time Frame |
|---|---|---|
| calcium (mg/dL) | change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests | 0-3-6 month |
| 25-OH vitamin D (ng/mL) | change of physiological parameter concentration related to calcium metabolism | 0-3-6 month |
| osteocalcin (ng/mL) | change of physiological parameter concentration related to calcium metabolism | 0-3-6 month |
| Parathyroid hormone (pg/mL) | change of physiological parameter concentration related to calcium metabolism | 0-3-6 month |
| Measure | Description | Time Frame |
|---|---|---|
| NMR metabolomic profile and applications of Metabolomics in calcium metabolism | Metabolomic profile of serum related to calcium metabolism by NMR proton Nuclear Magnetic Resonance spectroscopy (1H-NMR) Metabolomics aims at the quantitative analysis of all metabolites in a biological system, as well as their composition, interactions, and responses to interventions or a specific physiological state. The metabolomics approach correlates broad biochemical changes with health and disease states, and advanced statistical metabolic modeling allows the identification of biomarkers, enabling the quantification of low-molecular-weight metabolites |
| Measure | Description | Time Frame |
|---|---|---|
| changes cholesterol total (mg/dL) | change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests | 0-3-6 month |
| changes cholesterol HDL (mg/dL) | change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Salerno | Salerno | 84084 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15744450 | Background | 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. | |
| 18926940 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 27, 2021 | Apr 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2021 | Apr 7, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2021 | Apr 7, 2023 | ICF_002.pdf |
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| 0-3-6 month |
| 0-3-6 month |
| changes cholesterol LDL (mg/dL) | change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests | 0-3-6 month |
| changes glycemia (mg/dL) | change of physiological parameter concentration related to glycemic profile measured by blood laboratory tests | 0-3-6 month |
| 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. |