Children Clinical Trial
— PITNUTSOfficial title:
Comprehensive Dietary Assessment of Children Aged 1 Year to 6 Years (5-72 Months) - a Cross-sectional, Nationwide Study: PITNUTS 2024
A cross-sectional study representative of the Polish population of children aged 5 months to 6 years conducted in the cross-sectional study model, the main objective of which is to assess the nutritional value of the diet of children aged from 5 months to 6 years with regard to the basic macronutrients: protein (P), fat (F), carbohydrates (C). The study will include: dietary interviews, which will include the Food Frequency Questionnaire questionnaire (FFQ) and a 3-day food diary, as well as anthropometric measurements. The study will involve 1,000 children who will be selected by a random draw based on government database. The survey will be conducted by trained field interviewers - training will be provided by a dietician and an anthropologist. The study also included validation of the FFQ questionnaire.
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Months to 72 Months |
Eligibility | Inclusion Criteria: - healthy children aged 5 months to 72 months born at term - polish nationality Exclusion Criteria: - Presence of chronic diseases affecting nutritional status (metabolic diseases - e.g. diabetes, phenylketonuria, cystic fibrosis; diseases of the digestive system - e.g. coeliac disease, Crohn's disease; kidney disease, liver disease or other disorders affecting the absorption of nutrients) - Use of elimination diets for medical reasons (e.g. food allergy) - Developmental disorders that may affect nutrition (e.g. genetic diseases, prematurity) - Acute infectious disease or other illness requiring hospital treatment within 3 months prior to the start of the study - Condition after a prolonged hospital stay (>10 days) within 6 months prior to the study - Surgical procedures performed in the last 3 months that could affect nutritional status |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fundacja Nutricia | Institute of Mother and Child, Warsaw, Poland |
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Akkermans MD, Eussen SR, van der Horst-Graat JM, van Elburg RM, van Goudoever JB, Brus F. A micronutrient-fortified young-child formula improves the iron and vitamin D status of healthy young European children: a randomized, double-blind controlled trial. Am J Clin Nutr. 2017 Feb;105(2):391-399. doi: 10.3945/ajcn.116.136143. Epub 2017 Jan 4. — View Citation
Csolle I, Felso R, Szabo E, Metzendorf MI, Schwingshackl L, Ferenci T, Lohner S. Health outcomes associated with micronutrient-fortified complementary foods in infants and young children aged 6-23 months: a systematic review and meta-analysis. Lancet Child Adolesc Health. 2022 Aug;6(8):533-544. doi: 10.1016/S2352-4642(22)00147-X. Epub 2022 Jun 24. Erratum In: Lancet Child Adolesc Health. 2022 Dec;6(12):e28. — View Citation
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Fidler Mis N, Braegger C, Bronsky J, Campoy C, Domellof M, Embleton ND, Hojsak I, Hulst J, Indrio F, Lapillonne A, Mihatsch W, Molgaard C, Vora R, Fewtrell M; ESPGHAN Committee on Nutrition:. Sugar in Infants, Children and Adolescents: A Position Paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2017 Dec;65(6):681-696. doi: 10.1097/MPG.0000000000001733. — View Citation
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Hojsak I, Bronsky J, Campoy C, Domellof M, Embleton N, Fidler Mis N, Hulst J, Indrio F, Lapillonne A, Molgaard C, Vora R, Fewtrell M; ESPGHAN Committee on Nutrition. Young Child Formula: A Position Paper by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):177-185. doi: 10.1097/MPG.0000000000001821. — View Citation
Lapillonne A, Bronsky J, Campoy C, Embleton N, Fewtrell M, Fidler Mis N, Gerasimidis K, Hojsak I, Hulst J, Indrio F, Molgaard C, Moltu SJ, Verduci E, Domellof M; ESPGHAN Committee on Nutrition. Feeding the Late and Moderately Preterm Infant: A Position Paper of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):259-270. doi: 10.1097/MPG.0000000000002397. — View Citation
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dietary regime | Number of meals and snacking | the last 14 days of the FFQ | |
Other | Frequency of food consumption | Frequency of food consumption based on data from the FFQ | the last 14 days of the FFQ | |
Other | Dietary Patterns | Dietary patterns identified by two methods: predefined (diet quality indicators) and data-based (principal component factor analysis) | the last 14 days of the FFQ | |
Other | Dietary supplements | use of dietary supplements in children based on FFQ and food diaries | the last 14 days of the FFQ and three-day consumption from food diaries | |
Other | Nutritional Knowledge | level of declared nutritional knowledge of parents from questionairre | the last 14 days of the FFQ | |
Primary | Macronutrient intake | Nutritional value of the diet in terms of macronutrients: protein, fat, carbohydrates | three-day consumption | |
Secondary | Other nutrients intake | Nutritional value of the diet in terms of other nutrients: animal protein, vegetable protein, digestible carbohydrates, dietary fibre, lactose, sucrose, starch, polyunsaturated fatty acids (PUFA), monounsaturated fatty acids (MUFA), saturated fatty acids (SFA), vitamins, minerals (as well as in terms to primary nutrients: protein, fat, carbohydrates) will be calculated (per person/day) using the computer program (DIETA 6, National Food and Nutrition Institute, Warsaw) including Polish food composition tables. To collect dietary data 3-day estimated food record (FR) will be used. | three-day consumption | |
Secondary | Population risk of nutritional deficiencies | Based on nutrient intake cut-off point method [Estimated Average Requirement (EAR)/Adequate Intake (AI)] with a focus on vitamin D, Long-Chain Polyunsaturated Fatty Acids (LCPUFA) and protein | the last 14 days of the FFQ | |
Secondary | Nutritional status | Assessment of nutritional status based on Z-score BMI, or body mass index related to age and sex | At the time of the dietary interview |
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