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High- Versus Low-calcium Water for Bone Health

I

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)

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

Trial contacts and locations

1

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Central trial contact

Elena Cittera

Data sourced from clinicaltrials.gov

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