Focus: Nutritional DeficiencyNCT05777356
Sanitary Napkins for Urinary Assessment of Micronutrients
An observational study of Focus: Nutritional Deficiency, run by University of Hohenheim at 1 site in Germany.
Trial summary
This study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus: Nutritional Deficiency
- What is being tested?
- Urine collection and assessment of dietary intake by food frequency questionaire
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 8 Mar 2023to 9 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants are primarily recruited at the University of Hohenheim
Who may be able to join
- Healthy volunteers Written informed consent
Who cannot join
- BMI < 18,5 and >24,9 Use of medication (except contraceptives) Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Focus: Nutritional Deficiency
- Being tested
- Urine collection and assessment of dietary intake by food frequency questionaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine collection and assessment of dietary intake by food frequency questionaireDiagnostic test
urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements
| Study group | Role | What they receive |
|---|---|---|
| Omivorous | Healthy volunteers without dietary restrictions Receives: Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire | |
| Vegetarians | Healthy volunteers who do not consume meat products Receives: Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire | |
| Vegans | Healthy volunteers who do not consume any animal product Receives: Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8-9 weeks after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start8 Mar 2023
- Primary completion9 May 2023
- Study completion9 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Nutritional DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maren Podszun, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777356
- Sponsor's protocol ID
- NapUrine
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Collection of Urine From Sanitary Napkins for the Analysis of Micronutrient Deficiencies
- ClinicalTrials.gov ID
- NCT05777356
- Acronym / sponsor ID
- NapUrine
- Conditions
- Focus: Nutritional Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omivorous | – | Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaireHealthy volunteers without dietary restrictions |
| Vegetarians | – | Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaireHealthy volunteers who do not consume meat products |
| Vegans | – | Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaireHealthy volunteers who do not consume any animal product |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants are primarily recruited at the University of Hohenheim
Key inclusion criteria (1 listed)
- Healthy volunteers Written informed consent
Key exclusion criteria (1 listed)
- BMI < 18,5 and >24,9 Use of medication (except contraceptives) Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine collection and assessment of dietary intake by food frequency questionaireurinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements | Diagnostic test | Omivorous, Vegans, Vegetarians |
Primary outcome
Correlation untreated and expressed urine
Time frame: 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.
1 secondary outcome
Correlation of urinary biomarkers with food and supplement intake
Time frame: 8-9 weeks after completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus: Nutritional Deficiency, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation untreated and expressed urine (time frame: 8-9 weeks after completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.