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

May 2, 2023 updated by: Luca Rastrelli, University of Salerno
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Salerno, Italy, 84084
        • University of Salerno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bicarbonate-calcium water
participants of this group drink bicarbonate-calcium water
Other: bicarbonate-calcium water
water with high content of bicarbonate and calcium, low sodium
No Intervention: low mineral water
participants of this group drink low mineral water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
calcium (mg/dL)
Time Frame: 0-3-6 month
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)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
0-3-6 month
osteocalcin (ng/mL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
0-3-6 month
Parathyroid hormone (pg/mL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to calcium metabolism
0-3-6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NMR metabolomic profile and applications of Metabolomics in calcium metabolism
Time Frame: 0-3-6 month
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
0-3-6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes cholesterol total (mg/dL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests
0-3-6 month
changes cholesterol HDL (mg/dL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests
0-3-6 month
changes cholesterol LDL (mg/dL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests
0-3-6 month
changes glycemia (mg/dL)
Time Frame: 0-3-6 month
change of physiological parameter concentration related to glycemic profile measured by blood laboratory tests
0-3-6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salerno

Collaborators

San Giuseppe Moscati Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECN/1522

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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