NCT05777356

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

March 8, 2023

Last Update Submit

November 27, 2023

Conditions

Focus: Nutritional Deficiency

Outcome Measures

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.

    8-9 weeks after completion

Secondary Outcomes (1)

  • Correlation of urinary biomarkers with food and supplement intake

    8-9 weeks after completion

Other Outcomes (2)

  • Mean difference of urinary biomarkers between groups

    8-9 weeks after completion

  • Mean difference of urinary biomarkers between groups

    8-9 weeks after completion

Study Arms (3)

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

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

OmivorousVegansVegetarians

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants are primarily recruited at the University of Hohenheim

You may qualify if:

  • Healthy volunteers Written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

MeSH Terms

Interventions

Urine Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. rer. nat. Maren Podszun

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 21, 2023

Study Start

March 8, 2023

Primary Completion

May 9, 2023

Study Completion

May 9, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)