Sanitary Napkins for Urinary Assessment of Micronutrients

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

Detailed Description
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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.

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

Conditions
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Focus: Nutritional Deficiency

Intervention / Treatment
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* Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Written informed consent Exclusion Criteria: BMI < 18,5 and >24,9 Use of medication (except contraceptives) Smoking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omivorous<br>Healthy volunteers without dietary restrictions | Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire<br>* urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements<br>|
| Vegetarians<br>Healthy volunteers who do not consume meat products | Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire<br>* urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements<br>|
| Vegans<br>Healthy volunteers who do not consume any animal product | Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire<br>* urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements<br>|

What is the study measuring?
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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 |