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Sanitary Napkins for Urinary Assessment of Micronutrients

Pilot Study: Collection of Urine From Sanitary Napkins for the Analysis of Micronutrient Deficiencies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05777356
Enrollment
30
Registered
2023-03-21
Start date
2023-03-08
Completion date
2023-05-09
Last updated
2023-11-28

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

Conditions

Focus: Nutritional Deficiency

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTUrine 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

Sponsors

University of Hohenheim
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy volunteers Written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation untreated and expressed urine8-9 weeks after completionCorrelation of creatinine, methylmalonic acid and iodine between unprocessed urine and urine expressed from a sanitary diaper to evaluate possible matrix effects on analytes.

Secondary

MeasureTime frameDescription
Correlation of urinary biomarkers with food and supplement intake8-9 weeks after completionCorrelation of dietary intake assessed by a food frequency questionnaire with urinary iodine and methylmalonic acid normalized to creatinine.

Other

MeasureTime frameDescription
Mean difference of urinary biomarkers between groups8-9 weeks after completionExploratory analysis of differences by dietary group in urinary iodine nomalized to creatinin.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026