Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adults Nutrition as a Protective or Health-risk Factor (NUTRIHEALTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284840
Recruitment Status : Completed
First Posted : September 15, 2017
Last Update Posted : February 24, 2021
Sponsor:
Collaborators:
National Institute of Public Health, Slovenia
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Nutrition Institute, Slovenia

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Nutritional Status Nutrient Deficiency Micronutrient Deficiency Vitamin D Deficiency Vitamin B 12 Deficiency Folic Acid Deficiency Iron-deficiency Thyroid Diseases Diet Diagnostic Test: Assessement of nutritional status Diagnostic Test: Thyroid size

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 280 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: NUTRIHEALTH - Adults Nutrition as a Protective or Health-risk Factor
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : September 13, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Adults (18-65 years) Diagnostic Test: Assessement of nutritional status
Nutritional status for vitamin D, folic acid, vitamin B12 and iron.

Diagnostic Test: Thyroid size
Thyroid size by ultrasound.
Elderly (65-74 years) Diagnostic Test: Assessement of nutritional status
Nutritional status for vitamin D, folic acid, vitamin B12 and iron.

Diagnostic Test: Thyroid size
Thyroid size by ultrasound.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assessment of inadequate vitamin D status [ Time Frame: 1 year ]
    epidemiology of vitamin D status will be investigated

  2. Assessment of thyroid health [ Time Frame: 1 year ]
    epidemiology of thyroid Health will be investigated


Secondary Outcome Measures :
  1. Assessment of inadequate vitamin B12 status [ Time Frame: 1 years ]
    epidemiology of vitamin 12 status will be investigated

  2. Assessment of inadequate folic acid status [ Time Frame: 1 years ]
    epidemiology of folic acid status will be investigated

  3. Assessment of inadequate iron status [ Time Frame: 1 years ]
    epidemiology of iron status will be investigated


Biospecimen Retention:   Samples With DNA
Blood samples will be freezed for possible further analyses on markers related with nutrition & health

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

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

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284840


Locations
Layout table for location information
Slovenia
National Institute of Public Health, Slovenia
Ljubljana, Slovenia, 1000
Nutrition Institute, Ljubljana
Ljubljana, Slovenia, 1000
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Nutrition Institute, Slovenia
National Institute of Public Health, Slovenia
University Medical Centre Ljubljana
Investigators
Layout table for investigator information
Study Chair: Igor Pravst, PhD Nutrition Institute, Ljubljana
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Nutrition Institute, Slovenia
ClinicalTrials.gov Identifier: NCT03284840    
Other Study ID Numbers: KME72/07/16
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nutrition Institute, Slovenia:
dietary intake
nutritional status
micronutrients
thyroid health
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D Deficiency
Vitamin B 12 Deficiency
Folic Acid Deficiency
Thyroid Diseases
Endocrine System Diseases
 Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin B Deficiency