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CompletedNCT05777356Updated Nov 28, 2023

Sanitary Napkins for Urinary Assessment of Micronutrients

An observational study in Focus: Nutritional Deficiency, sponsored by University of Hohenheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by University of Hohenheim · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Focus: Nutritional Deficiency

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03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants are primarily recruited at the University of Hohenheim

Inclusion criteria

Healthy volunteers Written informed consent

Exclusion criteria

Exclusion Criteria:

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

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Omivorous

    Healthy volunteers without dietary restrictions

    Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire

  • Vegetarians

    Healthy volunteers who do not consume meat products

    Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire

  • Vegans

    Healthy volunteers who do not consume any animal product

    Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8-9 weeks after completion

Secondary outcomes

  1. 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.

    Time frame: 8-9 weeks after completion

Other outcomes

  1. Mean difference of urinary biomarkers between groups

    Exploratory analysis of differences by dietary group in urinary iodine nomalized to creatinin.

    Time frame: 8-9 weeks after completion

  2. Mean difference of urinary biomarkers between groups

    Exploratory analysis of differences by dietary group in methylmalonic acid nomalized to creatinin.

    Time frame: 8-9 weeks after completion

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Study locations

1 site
  • University of Hohenheim
    Stuttgart, Baden-Wuerttemberg 70599, Germany
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05777356
Lead sponsor
University of Hohenheim
Responsible party
Maren Podszun (Dr. rer. nat. Maren Podszun, University of Hohenheim) — Principal investigator
First posted
Mar 21, 2023
Start date
Mar 8, 2023
Primary completion
May 9, 2023
Completion
May 9, 2023
Last update
Nov 28, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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