High- Versus Low-calcium Water for Bone Health

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status: Enrolling

Conditions: Water-Electrolyte Imbalance; Orthopedic Disorder; Eating, Healthy; Calcium Metabolism Disorders; Bone Resorption

Treatments: Other: Loading of low-calcium water first, then high-calcium water

Study type: Interventional

Funder types: Other

Identifiers

NCT05772364

CALIMOS (PI: M Briguglio)

L4179 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 41 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Low-calcium water first, then high-calcium water

Experimental group

Description:

Participants drink 1.5 L of the designated water

Treatment:

Other: Loading of low-calcium water first, then high-calcium water