High- Versus Low-calcium Water for Bone Health

Sponsor

Istituto Ortopedico Galeazzi (Other)

Overall Status

Recruiting

CT.gov ID

NCT05772364

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorder Calcium Metabolism Disorders Bone Resorption Water-Electrolyte Imbalance Eating, Healthy	Other: Low-calcium water Other: High-calcium water	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

41 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Metabolic Response to the Consumption of Waters With Different Calcium Content: a Cross-over Clinical Study

Actual Study Start Date :

Mar 2, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Water loading phase 1 Participants drink 1.5 L of the designated water	Other: Low-calcium water All cohort subjects are asked to consume the amount of water within two hours Other Names: Water with less than 5 mg/L of calcium
Experimental: Water loading phase 2 Participants drink 1.5 L of the designated water	Other: High-calcium water All cohort subjects are asked to consume the amount of water within two hours Other Names: Water with at least 400 mg/L of calcium

Arm

Intervention/Treatment

Experimental: Water loading phase 1

Participants drink 1.5 L of the designated water

Other: Low-calcium water

All cohort subjects are asked to consume the amount of water within two hours

Other Names:

Water with less than 5 mg/L of calcium

Experimental: Water loading phase 2

Participants drink 1.5 L of the designated water

Other: High-calcium water

All cohort subjects are asked to consume the amount of water within two hours

Other Names:

Water with at least 400 mg/L of calcium

Outcome Measures

Primary Outcome Measures

Change of blood calcium levels [Baseline and 2.5 hours]
Change of calcium levels (mg/dL) from baseline and after 2.5 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)