High- Versus Low-calcium Water for Bone Health

April 27, 2026 updated by: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Milan, Milan, Italy
        • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-calcium water first, then high-calcium water
Participants drink 1.5 L of the designated water
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of blood calcium levels
Time Frame: Baseline and 2.5 hours
Change of calcium levels (mg/dL) from baseline and after 2.5 hours
Baseline and 2.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Matteo Briguglio, IRCCS Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Actual)

February 11, 2026

Study Completion (Actual)

April 23, 2026

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALIMOS (PI: M Briguglio)
  • L4179 (Other Grant/Funding Number: Italian Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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