High- Versus Low-calcium Water for Bone Health

NCT ID: NCT05772364

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-02

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Low-calcium water first, then high-calcium water

Participants drink 1.5 L of the designated water

Group Type EXPERIMENTAL

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

Intervention Type OTHER

All cohort subjects are asked to consume water with less than 5 mg/L of calcium first, then are asked to consume water with at least 400 mg/L of calcium

Interventions

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

All cohort subjects are asked to consume water with less than 5 mg/L of calcium first, then are asked to consume water with at least 400 mg/L of calcium

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matteo Briguglio

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Cittera

Role: CONTACT

00390283502224

Facility Contacts

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Elena Cittera

Role: primary

00390283502224

Other Identifiers

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L4179

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CALIMOS (PI: M Briguglio)

Identifier Type: -

Identifier Source: org_study_id

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