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 |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundacja Nutricia | Institute of Mother and Child, Warsaw, Poland |
Ahluwalia N, Herrick KA, Rossen LM, Rhodes D, Kit B, Moshfegh A, Dodd KW. Usual nutrient intakes of US infants and toddlers generally meet or exceed Dietary Reference Intakes: findings from NHANES 2009-2012. Am J Clin Nutr. 2016 Oct;104(4):1167-1174. doi: 10.3945/ajcn.116.137752. Epub 2016 Sep 14. — View Citation
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
Deren K, Weghuber D, Caroli M, Koletzko B, Thivel D, Frelut ML, Socha P, Grossman Z, Hadjipanayis A, Wyszynska J, Mazur A. Consumption of Sugar-Sweetened Beverages in Paediatric Age: A Position Paper of the European Academy of Paediatrics and the European Childhood Obesity Group. Ann Nutr Metab. 2019;74(4):296-302. doi: 10.1159/000499828. Epub 2019 Apr 23. — View Citation
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
Finn K, Callen C, Bhatia J, Reidy K, Bechard LJ, Carvalho R. Importance of Dietary Sources of Iron in Infants and Toddlers: Lessons from the FITS Study. Nutrients. 2017 Jul 11;9(7):733. doi: 10.3390/nu9070733. — View Citation
Hamner HC, Perrine CG, Scanlon KS. Usual Intake of Key Minerals among Children in the Second Year of Life, NHANES 2003-2012. Nutrients. 2016 Jul 30;8(8):468. doi: 10.3390/nu8080468. — View Citation
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
Lioret S, Betoko A, Forhan A, Charles MA, Heude B, de Lauzon-Guillain B; EDEN Mother-Child Cohort Study Group. Dietary patterns track from infancy to preschool age: cross-sectional and longitudinal perspectives. J Nutr. 2015 Apr;145(4):775-82. doi: 10.3945/jn.114.201988. Epub 2015 Jan 28. — View Citation
McCarthy EK, Ni Chaoimh C, Hourihane JO, Kenny LC, Irvine AD, Murray DM, Kiely M. Iron intakes and status of 2-year-old children in the Cork BASELINE Birth Cohort Study. Matern Child Nutr. 2017 Jul;13(3):e12320. doi: 10.1111/mcn.12320. Epub 2016 Aug 9. — View Citation
Schroeder N, Rushovich B, Bartlett E, Sharma S, Gittelsohn J, Caballero B. Early Obesity Prevention: A Randomized Trial of a Practice-Based Intervention in 0-24-Month Infants. J Obes. 2015;2015:795859. doi: 10.1155/2015/795859. Epub 2015 May 11. — View Citation
Weker H, Baranska M, Riahi A, Strucinska M, Wiech M, Rowicka G, Dylag H, Klemarczyk W, Bzikowska A, Socha P. Nutrition of infants and young children in Poland - Pitnuts 2016. Dev Period Med. 2017;21(1):13-28. doi: 10.34763/devperiodmed.20172101.1328. — View Citation
Weker H, Brudnicka E, Baranska M, Rowicka G, Strucinska M, Wiech M, Dylag H, Klemarczyk W, Socha P, Mazur J. Dietary Patterns of Children Aged 1-3 Years in Poland in Two Population Studies. Ann Nutr Metab. 2019;75(1):66-76. doi: 10.1159/000501422. Epub 2019 Jul 2. — View Citation
* 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03563196 -
Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
|
||
Completed |
NCT02553486 -
Internationally Adopted Children Quality of Life
|
N/A | |
Completed |
NCT02903134 -
Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
|
||
Completed |
NCT02918890 -
Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia
|
N/A | |
Active, not recruiting |
NCT01874847 -
PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin
|
Phase 2/Phase 3 | |
Enrolling by invitation |
NCT01971840 -
Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.
|
N/A | |
Enrolling by invitation |
NCT01971827 -
Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance
|
N/A | |
Completed |
NCT01738308 -
The Effects of Healing Touch on Post Operative Pediatric Patients
|
N/A | |
Completed |
NCT01693926 -
Effect of Physical Activity an Stress in Children
|
N/A | |
Completed |
NCT01864811 -
Effect of Baby-CIMT in Infants Younger Than 12 Months
|
N/A | |
Completed |
NCT01943760 -
Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty
|
Phase 4 | |
Completed |
NCT01323010 -
Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes
|
N/A | |
Completed |
NCT01277224 -
Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren
|
N/A | |
Active, not recruiting |
NCT00989547 -
Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)
|
Phase 1 | |
Completed |
NCT04051723 -
Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children
|
Phase 4 | |
Completed |
NCT03236363 -
Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!
|
N/A | |
Completed |
NCT03236337 -
Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!
|
N/A | |
Not yet recruiting |
NCT03427697 -
Effect of VR and Accommdation Relax on Controlling Myopia in Children
|
N/A | |
Completed |
NCT05603507 -
Inspiratory Muscle Training in Children With Chest Burn
|
N/A | |
Not yet recruiting |
NCT06267339 -
Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
|
Early Phase 1 |