High- Versus Low-calcium Water for Bone Health | NCT05772364

Studies
High- Versus Low-calcium Water for Bone Health

NCT05772364

Sponsor

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

Status

Completed

Last Update Posted

Apr 28, 2026Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

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

Interventions

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

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
L4179	Other Grant/Funding Number	Italian Ministry of Health

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2, 2023Actual

Primary Completion Date

Feb 11, 2026Actual

Completion Date

Apr 23, 2026Actual

First Submitted Date

Mar 6, 2023

First Submission Date that Met QC Criteria

Mar 6, 2023

First Posted Date

Mar 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2026

Last Update Posted Date

Apr 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low-calcium water first, then high-calcium water	Experimental	Participants drink 1.5 L of the designated water	Other: Loading of low-calcium water first, then high-calcium water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Loading of low-calcium water first, then high-calcium water	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matteo Briguglio	IRCCS Istituto Ortopedico Galeazzi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Istituto Ortopedico Galeazzi		Milan	Milan		Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009140	Musculoskeletal Diseases
D002128	Calcium Metabolism Disorders
D001862	Bone Resorption
D014883	Water-Electrolyte Imbalance

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001847	Bone Diseases

Browse Leaves

Not provided

Browse Branches

Not provided