Osteoporosis Risk
Conditions
Keywords
bicarbonate-calcium water
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
Interventions
OTHERbicarbonate-calcium water
water with high content of bicarbonate and calcium, low sodium
Sponsors
San Giuseppe Moscati Hospital
University of Salerno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| osteocalcin (ng/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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| changes cholesterol total (mg/dL) | 0-3-6 month | change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests |
| changes glycemia (mg/dL) | 0-3-6 month | change of physiological parameter concentration related to glycemic profile measured by blood laboratory tests |
| changes cholesterol LDL (mg/dL) | 0-3-6 month | change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests |
| changes cholesterol HDL (mg/dL) | 0-3-6 month | change of physiological parameter concentration related to lipidic profile measured by blood laboratory tests |
Countries
Italy
Outcome results
None listed