Nutritional StatusNUTRIHEALTHNCT03284840
Adults Nutrition as a Protective or Health-risk Factor
An observational study of Nutritional Status and Nutrient Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 3 sites in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency
- What is being tested?
- Assessement of nutritional status and Thyroid size
- How many people
- 280 participants
- Where
- 3 sitesSlovenia
- Study dates
- 1 Jun 2017to 31 Dec 2018
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Resident of Republic of Slovenia (included to the register of residents)
- Finished EU MENU Slovenia Study
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Slovenia3 sites
National Institute of Public Health, Slovenia
Ljubljana, 1000
Nutrition Institute, Ljubljana
Ljubljana, 1000
University Medical Centre Ljubljana
Ljubljana, 1000
About this study
Official title: NUTRIHEALTH - Adults Nutrition as a Protective or Health-risk Factor
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.
- Conditions
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency
- Being tested
- Assessement of nutritional status, Thyroid size
- Keywords
- dietary intake, nutritional status, micronutrients, thyroid health
- Medical subject headings
- Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency, Anemia, Iron-Deficiency, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessement of nutritional statusDiagnostic test
Nutritional status for vitamin D, folic acid, vitamin B12 and iron.
Thyroid sizeDiagnostic test
Thyroid size by ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Adults (18-65 years) | Not described Receives: Diagnostic Test: Assessement of nutritional status; Diagnostic Test: Thyroid size | |
| Elderly (65-74 years) | Not described Receives: Diagnostic Test: Assessement of nutritional status; Diagnostic Test: Thyroid size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of inadequate vitamin D status
epidemiology of vitamin D status will be investigated
Measured: 1 year
Assessment of thyroid health
epidemiology of thyroid Health will be investigated
Measured: 1 year
Secondary outcomes (3)
Assessment of inadequate vitamin B12 status
epidemiology of vitamin 12 status will be investigated
Measured: 1 years
Assessment of inadequate folic acid status
epidemiology of folic acid status will be investigated
Measured: 1 years
Assessment of inadequate iron status
epidemiology of iron status will be investigated
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start1 Jun 2017
- Primary completion13 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional StatusStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Igor Pravst, PhD, Study chair, Nutrition Institute, Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284840
- Sponsor's protocol ID
- KME72/07/16
- Acronym
- NUTRIHEALTH
- Status last verified
- Feb 2020
- First submitted
- 13 Sep 2017
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zaletel K, Tuta K, Usaj T, Studen KB, Bajuk NB, Jesenko M, Radevska T, Pirnat E, Gregoric M, Blaznik U, Hribar M, Pravst I, Gaberscek S. Occurrence of clinically relevant thyroid nodules in adults. Radiol Oncol. 2026 Jan 13;60(1):97-105. doi: 10.2478/raon-2026-0001. eCollection 2026 Mar 1.
PubMed 41527959
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NUTRIHEALTH - Adults Nutrition as a Protective or Health-risk Factor
- ClinicalTrials.gov ID
- NCT03284840
- Acronym / sponsor ID
- NUTRIHEALTH / KME72/07/16
- Conditions
- Nutritional Status, Nutrient Deficiency, Micronutrient Deficiency, Vitamin D Deficiency, Vitamin B 12 Deficiency, Folic Acid Deficiency
- Keywords
- dietary intake, nutritional status, micronutrients, thyroid health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, University Medical Centre Ljubljana
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 15 Sep 2017 (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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Resident of Republic of Slovenia (included to the register of residents)
- Finished EU MENU Slovenia Study
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Assessement of nutritional statusNutritional status for vitamin D, folic acid, vitamin B12 and iron. | Diagnostic test | Adults (18-65 years), Elderly (65-74 years) |
| Thyroid sizeThyroid size by ultrasound. | Diagnostic test | Adults (18-65 years), Elderly (65-74 years) |
Primary outcome
Assessment of inadequate vitamin D status
Time frame: 1 year
epidemiology of vitamin D status will be investigated
Assessment of thyroid health
Time frame: 1 year
epidemiology of thyroid Health will be investigated
3 secondary outcomes
Assessment of inadequate vitamin B12 status
Time frame: 1 years
Assessment of inadequate folic acid status
Time frame: 1 years
Assessment of inadequate iron status
Time frame: 1 years
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 24 Feb 2021.
- Derived from this study: PubMed 41527959Zaletel K, Tuta K, Usaj T, Studen KB, Bajuk NB, Jesenko M, Radevska T, Pirnat E, Gregoric M, Blaznik U, Hribar M, Pravst I, Gaberscek S. Occurrence of clinically relevant thyroid nodules in adults. Radiol Oncol. 2026 Jan 13;60(1):97-105. doi: 10.2478/raon-2026-0001. eCollection 2026 Mar 1.
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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.
Igor Pravst, PhD study chair
Nutrition Institute, Ljubljana
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status and Nutrient Deficiency, run by Institute of Nutrition, Slovenia (Nutris) at 3 sites in Slovenia.
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 2 inclusion and 3 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Slovenia. 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?
Assessment of inadequate vitamin D status (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284840, which also lists 1 linked publication.
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 24 Feb 2021.