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Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis

Primary Purpose

Osteoporosis Risk

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
bicarbonate-calcium water
Sponsored by
University of Salerno
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis Risk focused on measuring bicarbonate-calcium water

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Premenopausal women aged ≥40 years Menopausal women, period of early menopause 1-10 years Exclusion Criteria: Inclusion in other study protocols 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

Sites / Locations

  • University of Salerno

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

bicarbonate-calcium water

low mineral water

Arm Description

participants of this group drink bicarbonate-calcium water

participants of this group drink low mineral water

Outcomes

Primary Outcome Measures

calcium (mg/dL)
change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests
25-OH vitamin D (ng/mL)
change of physiological parameter concentration related to calcium metabolism
osteocalcin (ng/mL)
change of physiological parameter concentration related to calcium metabolism
Parathyroid hormone (pg/mL)
change of physiological parameter concentration related to calcium metabolism

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2023
Last Updated
May 2, 2023
Sponsor
University of Salerno
Collaborators
San Giuseppe Moscati Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05854342
Brief Title
Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
Official Title
Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salerno
Collaborators
San Giuseppe Moscati Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis Risk
Keywords
bicarbonate-calcium water

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bicarbonate-calcium water
Arm Type
Experimental
Arm Description
participants of this group drink bicarbonate-calcium water
Arm Title
low mineral water
Arm Type
No Intervention
Arm Description
participants of this group drink low mineral water
Intervention Type
Other
Intervention Name(s)
bicarbonate-calcium water
Intervention Description
water with high content of bicarbonate and calcium, low sodium
Primary Outcome Measure Information:
Title
calcium (mg/dL)
Description
change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests
Time Frame
0-3-6 month
Title
25-OH vitamin D (ng/mL)
Description
change of physiological parameter concentration related to calcium metabolism
Time Frame
0-3-6 month
Title
osteocalcin (ng/mL)
Description
change of physiological parameter concentration related to calcium metabolism
Time Frame
0-3-6 month
Title
Parathyroid hormone (pg/mL)
Description
change of physiological parameter concentration related to calcium metabolism
Time Frame
0-3-6 month
Secondary Outcome Measure Information:
Title
NMR metabolomic profile and applications of Metabolomics in calcium metabolism
Description
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
Time Frame
0-3-6 month
Other Pre-specified Outcome Measures:
Title
changes cholesterol total (mg/dL)
Description
change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests
Time Frame
0-3-6 month
Title
changes cholesterol HDL (mg/dL)
Description
change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests
Time Frame
0-3-6 month
Title
changes cholesterol LDL (mg/dL)
Description
change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests
Time Frame
0-3-6 month
Title
changes glycemia (mg/dL)
Description
change of physiological parameter concentration related to glycemic profile measured by blood laboratory tests
Time Frame
0-3-6 month

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Premenopausal women aged ≥40 years Menopausal women, period of early menopause 1-10 years Exclusion Criteria: Inclusion in other study protocols 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
Facility Information:
Facility Name
University of Salerno
City
Salerno
ZIP/Postal Code
84084
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15744450
Citation
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.
Results Reference
background
PubMed Identifier
18926940
Citation
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.
Results Reference
background

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Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis

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