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

Not Applicable

Completed

• Conditions: Osteoporosis Risk
• Interventions: Other: bicarbonate-calcium water

• Registration Number: NCT05854342
• Lead Sponsor: University of Salerno

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-04-01
• Study First Submitted: 2023-03-14
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-11
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bicarbonate-calcium water	bicarbonate-calcium water	participants of this group drink bicarbonate-calcium water

Primary Outcome Measures

Name	Time	Method
calcium (mg/dL)	0-3-6 month	change of some physiological parameters concentration related to calcium metabolism measured by blood laboratory tests
Parathyroid hormone (pg/mL)	0-3-6 month	change of physiological parameter concentration related to calcium metabolism
25-OH vitamin D (ng/mL)	0-3-6 month	change of physiological parameter concentration related to calcium metabolism
osteocalcin (ng/mL)	0-3-6 month	change of physiological parameter concentration related to calcium metabolism

Secondary Outcome Measures

Name	Time	Method
NMR metabolomic profile and applications of Metabolomics in calcium metabolism	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

Trial Locations

Locations (1)

University of Salerno; 🇮🇹 Salerno, Italy