NUTRIHEALTH: Adults Nutrition as a Protective or Health-risk Factor

• Sponsor: Nutrition Institute, Slovenia (Other)
• Overall Status: Completed
• CT.gov ID: NCT03284840
• Collaborator: National Institute of Public Health, Slovenia (Other), University Medical Centre Ljubljana (Other)
• Enrollment: 280
• Locations: 3
• Actual Duration (Months): 19
• Patients Per Site: 93.3
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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	Phase
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

• 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: Jun 1, 2017
• Actual Primary Completion Date: Sep 13, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Assessment of inadequate vitamin D status [1 year]

   epidemiology of vitamin D status will be investigated

2. Assessment of thyroid health [1 year]

   epidemiology of thyroid Health will be investigated

Secondary Outcome Measures

1. Assessment of inadequate vitamin B12 status [1 years]

   epidemiology of vitamin 12 status will be investigated

2. Assessment of inadequate folic acid status [1 years]

   epidemiology of folic acid status will be investigated

3. Assessment of inadequate iron status [1 years]

   epidemiology of iron status will be investigated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Public Health, Slovenia	Ljubljana		Slovenia	1000
2	Nutrition Institute, Ljubljana	Ljubljana		Slovenia	1000
3	University Medical Centre Ljubljana	Ljubljana		Slovenia	1000

Sponsors and Collaborators

• Nutrition Institute, Slovenia
• National Institute of Public Health, Slovenia
• University Medical Centre Ljubljana

Investigators

• Study Chair: Igor Pravst, PhD, Nutrition Institute, Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nutrition Institute, Slovenia
• ClinicalTrials.gov Identifier: NCT03284840
• Other Study ID Numbers: KME72/07/16
• First Posted: Sep 15, 2017
• Last Update Posted: Feb 24, 2021
• Last Verified: Feb 1, 2020

• 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: Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Thyroid Diseases

Study Results

No Results Posted as of Feb 24, 2021