Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT06096194
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D3-enhanced Eggs in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'C564005', 'term': 'Vitamin D Hydroxylation-Deficient Rickets, Type 1B'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Two types of eggs. Control egg and fortified egg (vitamin D3-enhanced egg), only the researcher in charge of eggs production was not blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Double Blind field trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2019-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2023-09-04', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insulin', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'ug/dL'}, {'measure': 'Weight', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'kg'}, {'measure': 'Height', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'cm'}, {'measure': 'Total Cholesterol', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'mg/dL'}, {'measure': 'Triglicerids', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'mg/dL'}, {'measure': 'HDLc', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'mg/dL'}, {'measure': 'Glucose', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'mg/dL'}], 'primaryOutcomes': [{'measure': 'Serum 25-OH-D', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'nmol/L'}], 'secondaryOutcomes': [{'measure': 'Serum PTH', 'timeFrame': 'At baseline and at 12 weeks of intervention', 'description': 'pcg/mL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin D3', 'enhanced egg', 'Vitamin D3-enhanced egg', '25-Hydroxyvitamin D3 Deficiency', 'supplementation', 'Mexico', 'Children'], 'conditions': ['Vitamin D Deficiency', '25-Hydroxyvitamin D3 Deficiency, Selective']}, 'descriptionModule': {'briefSummary': 'This is double-blind, controlled fiel trial, to compare fortified egg with D3-or 25(OH)D3 and non-fortified eggs in healthy preschool-age children 12 to 60 months of age, affiliated to day-care centers at Secretaria de Desarrollo Social (SEDESOL).\n\nThe study aims to answer are:\n\n1. to evaluate the efficacy of fortified egg with vitamian D3 on serum concentrations of 25-hydroxyvitamin D3\n2. and to evaluate parathyroid hormone (PTH) in children aged 12 to 60 months of age.\n\n * Children would be given for breakfast fortified egg/non-foritfied egg three times per week for 12 weeks.\n * Blood samples will be taken at baseline and at the end of study.\n * Anthropometric meassurements weight /height will be taken at baseline and at end of study.', 'detailedDescription': "1. Vitamin D functions:\n\n Vitamin D (VD) is a fat-soluble vitamin. Its main function is to maintain optimal levels of calcium and phosphorus in the body; it also helps in neuromuscular transmission and bone mineralization, important in bone health and growth in children. There are VD receptors in bone, bone marrow, adipose tissue, adrenal, brain, stomach, small intestine, colon, pancreas, liver, lung, muscle, activated B and T lymphocytes, and in other organs, tissues, and cells. For this reason, various functions are assumed. VD serum concentrations above 75 mmol/l (30 ng/ml) have been shown to keep cell growth under control and prevent cells from becoming autonomous and malignant.\n2. Prevalences of vitamin D deficiencies and insufficiency:\n\n Worldwide, a high proportion of children, youth, and middle-aged adults are deficient in Vitamin D. It has been estimated that about one billion people in the world may be deficient in Vitamin D.\n\n In Latin America, only Mexico has representative population data on vitamin D deficiency. Recently it has been documented that the deficiency and insufficiency of Vitamin D are a public health problem in Mexico. In a national representative sample of 6,827 children aged 1 to 11 years who participated in the 2012 National Health and Nutrition Survey (ENSANUT), the prevalence of Vitamin D deficiency was 33% (25-OH-D \\<50 nmol/L), which means that there are 3 million children with Vitamin D deficiency in Mexico. On the other hand, insufficiency (25-OH-D of 50 \\<75 nmol/L) affects 56% of children. Likewise, it was found that less than 3% of children consume a supplement with Vitamin D.\n3. Vitamin D intake recommendations in children:\n\n The current vitamin D intake recommendations made by the APP since 2008 (Wagner CL, 2008) for children aged 1 to 8 years is an Adequate Intake of 400-600 IU (10-15µg), and for the Tolerable Upper Intake Level it is suggested do not exceed 2500 IU (63µg) in the case of children from 1 to 3 years and 3000 IU (75µg) in children from 4 to 8 years.\n4. Description of the study:\n\n A double-blind controlled cluster randomized field trial was developed.\n\n The participants were children from 6 day-care centers (SEDESOL) at Cuernavaca, Morelos, Mexico. The study sample had 275 children that completed the study (the protocol considered having at least 125 children in each treatment group), from 12 to 59 months, who attended 6 take care centers (SEDESOL), in Cuernavaca, Morelos.\n5. Objective\n\n To evaluate the efficacy of the consumption of fortified eggs with Vitamin D3 on the serum concentrations of 25-OH-D in children aged 12 to 59 months who attend take care centers (SEDESOL)in Cuernavaca.\n6. Treatment and control groups:\n\n The random assignments of the intervention group (fortified egg) and control group (unfortified egg) were done considering each day-care center as a unit of allocation.\n\n Three day-care centers were randomized to the intervention group and three to the control group. The study lasted 12 weeks.\n\n The treatment group consumed a fortified egg to provide 10 mcg of Vitamin D3 equivalent to 400 IU of Cholecalciferol, 3 times a week.\n\n The control group received unfortified egg (\\~ 43 IU Vitamin D) with the same frequency as the intervention group.\n7. Main Outcomes:\n\n The main outcome outcome variables were the serum levels of 25-hydroxyvitamin D3 (25-OH-D3) The second main outcome was to evaluate the parathyroid hormone (PTH).\n\n Other Variables:\n\n Blood parameters were taken: total cholesterol, HDL cholesterol, triglycerides, glucose, and hemoglobin.\n\n Anthropometric measurements of weight, height, age.\n\n Morbidity (diarrhea, constipation and respiratory tract infections) was evaluated three times per week and recorded.\n\n Standardized personnel weight the egg consumed before and after breakfast with a food weighing scale.\n\n Mothers were asked about children's usual diet by two diet questionnaires : a 24-hour dietary recall and a food frequency questionnaire at baseline and at the end of the study.\n8. Ethical considerations:\n\nThe protocol was submitted to he Research and Ethics Committee of the Medicine Research Division of the National Autonomous University of Mexico.The study was approved on May 8, 2018 with folio FM/DI/028/2018.\n\nThe children's mothers or guardians signed an informed consent letter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '59 Months', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children of either sex, from 12 to 59 months of age who attend take care SEDESOL centers\n* Children who consume eggs within their usual diet at least 5 times per month\n* Childrens whose parents or legal guardian agree to participate in the study and sign an informed consent letter\n\nExclusion Criteria:\n\n* Children with an egg allergy\n* Chldren with hypersensitivity to vitamin D\n* Children who have taken vitamin D supplements in the past month'}, 'identificationModule': {'nctId': 'NCT06096194', 'acronym': 'VD3-egg', 'briefTitle': 'Vitamin D3-enhanced Eggs in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Salud Publica, Mexico'}, 'officialTitle': 'Effect of the Consuption of Vitamin D3-enhanced Eggs on Serum 25-hydroxivitamin D[(25-OH)D3] and Parathyroid Hormone (PTH) in Preschool Children', 'orgStudyIdInfo': {'id': 'FM/DI/0282018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vitamin D3-enhanced egg', 'description': 'The experimental group consumed an vitamin D3-enhanced egg (\\~ 400 IU). The randomization unit was the take care SEDESOL centers. All children in 3 day-care centers were given one vitamin D3-enhanced egg at breakfast, 3 times a week for 12 weeks (Monday, Wednesday and Friday).', 'interventionNames': ['Dietary Supplement: vitamin D-enhanced egg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The control group consumed unfortified egg (\\~ 43 IU Vitamin D). The randomization unit was the 6 day-care centers (SEDESOL). All children in 3 day-care centers were given unfortified egg at breakfast, 3 times a week for 12 weeks (Monday, Wednesday and Friday).', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'vitamin D-enhanced egg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In our study, the vitamin D3-enhanced eggs were produced by hens that received 23,500 IU of vitamin D3 per kg of feed. Which does not confer them any harm or danger of intoxication. This experiment was carried out at the Center for Teaching, Research and Extension in Poultry Production (CEIEPAv, FMVZ-UNAM) and lasted 40 weeks.\n\nThis ensured that the hens eggs were enhanced with vitamin D achieving a final concentration of approximately 400 IU of vitamin D', 'armGroupLabels': ['vitamin D3-enhanced egg']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Unfortified eggs were used for the control group with a concentration of approximately 43 IU of vitamin D', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62100', 'city': 'Cuernavaca', 'state': 'Morelos', 'country': 'Mexico', 'facility': 'Instituto Nacional de Salud Pública', 'geoPoint': {'lat': 18.9261, 'lon': -99.23075}}], 'overallOfficials': [{'name': 'Mario E Flores Aldana, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Public Health, Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Salud Publica, Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mario Flores-Aldana, MD, PhD Nutrition Surveillance, Director', 'investigatorFullName': 'Mario Flores-Aldana', 'investigatorAffiliation': 'Instituto Nacional de Salud Publica, Mexico'}}}}