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CompletedNCT03284840NUTRIHEALTHUpdated Feb 24, 2021

Adults Nutrition as a Protective or Health-risk Factor

An observational study in Nutritional Status, Nutrient Deficiency and Micronutrient Deficiency, sponsored by Nutrition Institute, Slovenia. Completed at 3 sites in Slovenia. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by Nutrition Institute, Slovenia · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
280
Ages
18 Years to 74 Years
Sex
All
01

Study summary

To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the consumption of foods and enabling the assessment of energy and macronutrient intakes. Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination, in which thyroid size will be aslo measured, to investigated thyroid epidemiology in Slovenia.

02

Conditions studied

  • Nutritional Status
  • Nutrient Deficiency
  • Micronutrient Deficiency
  • Vitamin D Deficiency
  • Vitamin B 12 Deficiency
  • Folic Acid Deficiency
  • Iron-deficiency
  • Thyroid Diseases
  • Diet

Keywords

  • dietary intake
  • nutritional status
  • micronutrients
  • thyroid health
03

In context

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

This study's enrollment of 280 is above the median of 138 across 185 observational studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Nutrition Institute, Slovenia is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

This observational study is conducted on randomly selected residents of Republic of Slovenia. The EU Menu study (LOT2) include a minimum of 1.133 of habitants from Slovenia in the age 18-74 years. In line with the EU Menu methodology and to ensure representativeness of the sample, participants will be randomly selected from the Slovenian population using Central Population Register (selection outsourced by the Statistical Office of Republic of Slovenia ), and visited on their home. After completion of the EU Menu Survey (questionnaires on self-reported health status and food intake), participants will be invited to collaborate in the proposed study.

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.

Inclusion criteria

  • Resident of Republic of Slovenia (included to the register of residents)
  • Finished EU MENU Slovenia Study

Exclusion criteria

Exclusion Criteria:

  • Not willing to give blood\&urine sample
  • Long-term disease
  • Living in institutions with controled diet, such as such as in elderly care, hospital, prison, etc.
05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
280 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adults (18-65 years)

    Diagnostic Test: Assessement of nutritional status · Diagnostic Test: Thyroid size

  • Elderly (65-74 years)

    Diagnostic Test: Assessement of nutritional status · Diagnostic Test: Thyroid size

Interventions

  • Diagnostic testAssessement of nutritional status

    Nutritional status for vitamin D, folic acid, vitamin B12 and iron.

  • Diagnostic testThyroid size

    Thyroid size by ultrasound.

06

What researchers measure

Primary outcomes

  1. Assessment of inadequate vitamin D status

    epidemiology of vitamin D status will be investigated

    Time frame: 1 year

  2. Assessment of thyroid health

    epidemiology of thyroid Health will be investigated

    Time frame: 1 year

Secondary outcomes

  1. Assessment of inadequate vitamin B12 status

    epidemiology of vitamin 12 status will be investigated

    Time frame: 1 years

  2. Assessment of inadequate folic acid status

    epidemiology of folic acid status will be investigated

    Time frame: 1 years

  3. Assessment of inadequate iron status

    epidemiology of iron status will be investigated

    Time frame: 1 years

07

Study locations

3 sites
  • National Institute of Public Health, Slovenia
    Ljubljana, 1000, Slovenia
  • Nutrition Institute, Ljubljana
    Ljubljana, 1000, Slovenia
  • University Medical Centre Ljubljana
    Ljubljana, 1000, Slovenia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Sep 2018, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2017
First posted
Sep 15, 2017
StartActual
Jun 1, 2017
Primary completionActual
Sep 13, 2018
CompletionActual
Dec 31, 2018
Last update
Feb 24, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03284840
Lead sponsor
Nutrition Institute, Slovenia
Collaborators
National Institute of Public Health, Slovenia, University Medical Centre Ljubljana
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Jun 1, 2017
Primary completion
Sep 13, 2018
Completion
Dec 31, 2018
Last update
Feb 24, 2021

Study contacts

Igor Pravst, PhD
study chair · Nutrition Institute, Ljubljana

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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