Sanitary Napkins for Urinary Assessment of Micronutrients

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

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

Study Overview

• Status: Completed
• Conditions: Focus: Nutritional Deficiency
• Intervention / Treatment: Diagnostic test: Urine collection and assessment of dietary intake by food frequency questionaire

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Stuttgart, Baden-Wuerttemberg, Germany, 70599
      • University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants are primarily recruited at the University of Hohenheim

Description

Inclusion Criteria:

Healthy volunteers Written informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Omivorous; Healthy volunteers without dietary restrictions	Diagnostic test: 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
Vegetarians; Healthy volunteers who do not consume meat products	Diagnostic test: 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
Vegans; Healthy volunteers who do not consume any animal product	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation untreated and expressed urine	Correlation of creatinine, methylmalonic acid and iodine between unprocessed urine and urine expressed from a sanitary diaper to evaluate possible matrix effects on analytes.	8-9 weeks after completion

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean difference of urinary biomarkers between groups	Exploratory analysis of differences by dietary group in urinary iodine nomalized to creatinin.	8-9 weeks after completion
Mean difference of urinary biomarkers between groups	Exploratory analysis of differences by dietary group in methylmalonic acid nomalized to creatinin.	8-9 weeks after completion

Collaborators and Investigators

• Sponsor: University of Hohenheim

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 9, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: NapUrine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No