normal pregnancy
Conditions
Interventions
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
Sponsors
Kumamoto University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The sample size was calculated using the statistical software G Power, resulting in 26 respondents. Assuming a drop rate of 10-20%, and based on the results of a preliminary background investigation (background questionnaire: check gender, age, allergies, and pre-existing medical conditions), the number of study subjects who met the study objectives was set at 60 (30 in the control group and 30 in the low-sodium seasoning group). The subjects will be pregnant women who have been undergoing regular antenatal checkups at the outpatient department of obstetrics and gynecology at Kumamoto University Hospital from 14 weeks to 32 weeks gestation and who do not meet the following exclusion criteria.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYutaka Iwagoe
Kumamoto University Hospital Department of Obstetrics and Gynecology
Outcome results
None listed