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

University of Salerno120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

120

Conditions

Osteoporosis Risk

Interventions

bicarbonate-calcium waterOTHER

water with high content of bicarbonate and calcium, low sodium

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Salerno

Salerno, Italy

Outcomes

Primary Outcomes

calcium (mg/dL)

change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests

Time frame: 0-3-6 month

25-OH vitamin D (ng/mL)

change of physiological parameter concentration related to calcium metabolism

Time frame: 0-3-6 month

osteocalcin (ng/mL)

change of physiological parameter concentration related to calcium metabolism

Time frame: 0-3-6 month

Parathyroid hormone (pg/mL)

change of physiological parameter concentration related to calcium metabolism

Time frame: 0-3-6 month

Secondary Outcomes

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

Time frame: 0-3-6 month

Data from ClinicalTrials.gov

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