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Clinical Trials/NCT05777356
NCT05777356
Completed
Not Applicable

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

University of Hohenheim1 site in 1 country30 target enrollmentMarch 8, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Focus: Nutritional Deficiency
Sponsor
University of Hohenheim
Enrollment
30
Locations
1
Primary Endpoint
Correlation untreated and expressed urine
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 8, 2023
End Date
May 9, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maren Podszun

Dr. rer. nat. Maren Podszun

University of Hohenheim

Eligibility Criteria

Inclusion Criteria

  • Healthy volunteers Written informed consent

Exclusion Criteria

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

Outcomes

Primary Outcomes

Correlation untreated and expressed urine

Time Frame: 8-9 weeks after completion

Correlation of creatinine, methylmalonic acid and iodine between unprocessed urine and urine expressed from a sanitary diaper to evaluate possible matrix effects on analytes.

Secondary Outcomes

  • Correlation of urinary biomarkers with food and supplement intake(8-9 weeks after completion)

Study Sites (1)

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