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
This study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status.
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's enrollment of 30 is below the median of 206 across 393 observational studies indexed under Malnutrition.
Browse Malnutrition studies →University of Hohenheim is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants are primarily recruited at the University of Hohenheim
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy volunteers Written
Exclusion Criteria:
\< 18,5 and >24,9 Use of medication (except ) Smoking
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers without dietary restrictions
Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire
Healthy volunteers who do not consume meat products
Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2023 to primary completion in May 2023, 2 months.
Of 174 non-industry observational studies under Malnutrition, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 2 months is below that.
Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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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University of Hohenheim