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Completed

NCT Number: NCT05854342

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

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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Key information

Conditions

Osteoporosis Risk

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Salerno

Salerno, 84084, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bicarbonate-calcium water

Other

water with high content of bicarbonate and calcium, low sodium

Primary outcomes

  1. calcium (mg/dL)

    Time frame: 0-3-6 month

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

  2. 25-OH vitamin D (ng/mL)

    Time frame: 0-3-6 month

    change of physiological parameter concentration related to calcium metabolism

  3. osteocalcin (ng/mL)

    Time frame: 0-3-6 month

    change of physiological parameter concentration related to calcium metabolism

  4. Parathyroid hormone (pg/mL)

    Time frame: 0-3-6 month

    change of physiological parameter concentration related to calcium metabolism

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. changes glycemia (mg/dL)

    Time frame: 0-3-6 month

    change of physiological parameter concentration related to glycemic profile measured by blood laboratory tests

Sponsors and collaborators

Lead sponsor

University of Salerno

Other

Collaborators

  • San Giuseppe Moscati Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 11, 2023
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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