Alteration of salt intake and urinary excretion in pregnant women by low-sodium seasonings

UMIN ID: UMIN000056939

Registered date:05/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: normal pregnancy
• Date of first enrollment: 2025/02/05
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

During the 4-week observation period, patients will be allowed to consume low-sodium seasonings (amount to be determined by the patient), with a maximum daily intake of 3 g (up to 1 g per meal) and no lower limit.Conduct an interview (about 10 minutes) on low-sodium seasoning intake.
control group

Outcome(s)

• Primary Outcome: To examine whether there is a change in urinary salt excretion in pregnant and nursing women due to the intake of low-sodium seasonings.
• Secondary Outcome: Evaluate changes in excretion of other nutritional items excreted into urine due to intake of low-sodium seasonings. (Evaluation parameters: urinary calcium, urinary magnesium, urinary vitamin C, urinary zinc, urinary iron) (Safety endpoints) Adverse events Laboratory values Vital signs

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Female
• Exclude criteria: 1. twins 2. expectant mothers at risk of premature delivery 3. those in an immediate and obvious life-threatening situation 4. expectant and nursing mothers under 20 years of age 5. expectant and nursing mothers of non-Japanese nationality 6. other persons judged to be inappropriate by the principal investigator or subinvestigators.

Related Information

• Primary Sponsor: Kumamoto University
• Source(s) of Monetary Support: self-financing