Orthopedic Disorder Clinical Trial
Official title:
Metabolic Response to the Consumption of Waters With Different Calcium Content: a Cross-over Clinical Study
The experimental study investigates which metabolic responses of calcium and parathyroid hormone are observable in blood and urine in a cohort of 41 healthy adults following a sequence of different exposures: low-calcium water first and high-calcium water afterward.
| Status | Recruiting |
| Enrollment | 41 |
| Est. completion date | May 31, 2026 |
| Est. primary completion date | March 31, 2026 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 25 Years to 55 Years |
| Eligibility | Inclusion Criteria: - Body mass index = 18 and < 30 - Maintenance of diet and physical activity lifestyle throughout the duration of the study - Acceptance of informed consent Exclusion Criteria: - Consumption of water with calcium > 150 mg/L - Pregnancy (as established by self-declaration), breastfeeding, menopause - Inability to follow the study protocol - Cardiac, vascular, renal, and oncological disease - Neuropsychiatric disease, developmental disorders - Disease or past surgery affecting the gastrointestinal tract - Drugs that interfere with bone (e.g. corticosteroids) or with fluid balance (e.g. diuretics) |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Istituto Ortopedico Galeazzi | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Ortopedico Galeazzi |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of blood calcium levels | Change of calcium levels (mg/dL) from baseline and after 2.5 hours | Baseline and 2.5 hours |
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