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Sanitary Napkins for Urinary Assessment of Micronutrients

NCT ID: NCT05777356

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-05-09

Brief Summary

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This study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status.

Detailed Description

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Urinary collection in newborns and infants can be difficult. Our study aims to find an easy and cheap alternative to urinary collection bags and specialized pads that can be used to measure biomarkers of iodine and vitamin B12 status in urine and can be employed in large scale trials. Using correlation analyses, the association of urinary iodine and methylmalonic acid from healthy volunteers will be assessed between untreated sample and a sample expressed from a sanitary napkin. Participants will be recruited based on their dietary pattern (omnivorous, vegetarian and vegans) to have a broad spectrum of analyte concentration. Participants weight, height, age, nutritional supplement use and diet will be assessed.

Conditions

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Focus: Nutritional Deficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Omivorous

Healthy volunteers without dietary restrictions

Urine collection and assessment of dietary intake by food frequency questionaire

Intervention Type DIAGNOSTIC_TEST

urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements

Vegetarians

Healthy volunteers who do not consume meat products

Urine collection and assessment of dietary intake by food frequency questionaire

Intervention Type DIAGNOSTIC_TEST

urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements

Vegans

Healthy volunteers who do not consume any animal product

Urine collection and assessment of dietary intake by food frequency questionaire

Intervention Type DIAGNOSTIC_TEST

urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements

Interventions

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Urine collection and assessment of dietary intake by food frequency questionaire

urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Healthy volunteers Written informed consent

Exclusion Criteria

BMI \< 18,5 and \>24,9 Use of medication (except contraceptives) Smoking
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Hohenheim

OTHER

Sponsor Role lead

Responsible Party

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Maren Podszun

Dr. rer. nat. Maren Podszun

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Hohenheim

Stuttgart, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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NapUrine

Identifier Type: -

Identifier Source: org_study_id