Sanitary Napkins for Urinary Assessment of Micronutrients

Completed

• Conditions: Focus: Nutritional Deficiency
• Interventions: Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire

• Registration Number: NCT05777356
• Lead Sponsor: University of Hohenheim

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.

Study Timeline

• Study Start: 2023-03-08
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-21
• Primary Completion: 2023-05-09
• Study Completion: 2023-05-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Healthy volunteers Written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vegetarians	Urine collection and assessment of dietary intake by food frequency questionaire	Healthy volunteers who do not consume meat products
Omivorous	Urine collection and assessment of dietary intake by food frequency questionaire	Healthy volunteers without dietary restrictions
Vegans	Urine collection and assessment of dietary intake by food frequency questionaire	Healthy volunteers who do not consume any animal product

Primary Outcome Measures

Name	Time	Method
Correlation untreated and expressed urine	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 Outcome Measures

Name	Time	Method
Correlation of urinary biomarkers with food and supplement intake	8-9 weeks after completion	Correlation of dietary intake assessed by a food frequency questionnaire with urinary iodine and methylmalonic acid normalized to creatinine.

Trial Locations

Locations (1)

University of Hohenheim; 🇩🇪 Stuttgart, Baden-Wuerttemberg, Germany