UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056939 |
|---|---|
| Receipt number | R000064643 |
| Scientific Title | Effects of using low-sodium seasonings on changes in salt intake and urinary excretion in pregnant women |
| Date of disclosure of the study information | 2025/02/05 |
| Last modified on | 2025/02/05 09:08:00 |
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Basic information
Public title
Alteration of salt intake and urinary excretion in pregnant women by low-sodium seasonings
Acronym
Alteration of salt intake and excretion in pregnant women by low-sodium seasonings
Scientific Title
Effects of using low-sodium seasonings on changes in salt intake and urinary excretion in pregnant women
Scientific Title:Acronym
Effect of low-sodium seasonings on urinary excretion in pregnant women
Region
| Japan |
Condition
Condition
normal pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Gestational hypertension is a known trigger for fetal growth retardation and HELLP syndrome. While antihypertensive medications for pregnant and nursing women are limited, healthcare providers actively promote salt reduction guidance. However, ensuring adequate nutrient intake while reducing salt consumption during pregnancy is difficult, particularly due to decreased food intake and selective eating patterns associated with hyperemesis gravidarum.
Alginic acid, first extracted from seaweed in 1883, is a heteropolymer composed of D-mannuronic acid (M) and L-guluronic acid (G). Salt-adsorbing fibers, primarily alginates, bind to sodium in the intestinal tract and facilitate its direct excretion in stool. Studies using a salt-loading model have demonstrated that alginates bind to sodium through ion-exchange reactions and suppress its gastrointestinal absorption, thereby inhibiting increases in blood sodium concentration while enhancing fecal sodium excretion (Fujiwara et al., Heliyon, 2021). When consumed simultaneously with salt, alginates bind to sodium in the digestive tract and are excreted in feces while maintaining this binding, effectively reducing sodium absorption into the bloodstream.
This study aims to evaluate the effectiveness of salt-absorbing fiber containing alginate and other salt-absorbing fibers (low-sodium seasonings) on urinary excretion and salt intake in pregnant and nursing mothers receiving care at the Department of Obstetrics and Gynecology, Kumamoto University Hospital. Additionally, we will assess whether the consumption of low-sodium seasonings affects the intake of other essential nutrients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine whether there is a change in urinary salt excretion in pregnant and nursing women due to the intake of low-sodium seasonings.
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
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.
Interventions/Control_2
control group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key 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.
Key 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.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Kondoh |
Organization
Kumamoto University
Division name
Department of Obstetrics and Gynecology, Faculty of Life Sciences
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5269
kondoh@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Iwagoe |
Organization
Kumamoto University Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5269
Homepage URL
yutaka.i.0719.gyn@gmail.com
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Eiji Kondoh
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yutaka Iwagoe
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
Tel
096-373-5269
yutaka.i.0719.gyn@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064643
