Palatability of different urea oral formulations used in the treatment of low blood sodium levels

Palatability of two different formulations of urea for the treatment of hyponatremia: a double-blind, cross-over study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18369035

Enrollment

Registered

2023-06-26

Start date

2023-04-27

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia Nutritional, Metabolic, Endocrine Hypo-osmolality and hyponatraemia

Interventions

The study evaluated the palatability of two urea formulations and was divided into two cross-over phases. Each participant consumed formulation A or formulation B twice a day away from meals, solubili

the galenic formulation contains only urea. Participants consumed 7 g of each product (formulation A or formulation B) twice daily, solubilized in 125 ml of water.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 50-60 years 2. 50% female and 50% male 3. Non-smokers

Exclusion criteria

Exclusion criteria: 1. Personal history of taste disorders 2. Presence of conditions capable of altering the sense of taste

Design outcomes

Primary

Measure	Time frame
Product palatability measured using a questionnaire modified from IJpma et al (2016) filled in by the test subjects after each intake on T0 and T4	—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Italy

Contacts

Public ContactMassimo;Francesca Milani;Colombo

;

massimo.milani@difacooper.com;francesca.colombo@difacooper.com+39 (0)29659031;+39 (0)29659031

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026