An interventional study of vitamin D-enhanced egg and Control in Vitamin D Deficiency and 25-Hydroxyvitamin D3 Deficiency, Selective, sponsored by Instituto Nacional de Salud Publica, Mexico. Completed at 1 site in Mexico. Open to participants aged 12 Months to 59 Months. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Instituto Nacional de Salud Publica, Mexico · Not applicable, Interventional, and Treatment
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).
The study aims to answer are:
and to evaluate parathyroid hormone (PTH) in children aged 12 to 60 months of age.
Vitamin D functions:
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.
Prevalences of vitamin D deficiencies and insufficiency:
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.
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.
Vitamin D intake recommendations in children:
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.
Description of the study:
A double-blind controlled cluster randomized field trial was developed.
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.
Objective
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.
Treatment and control groups:
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.
Three day-care centers were randomized to the intervention group and three to the control group. The study lasted 12 weeks.
The treatment group consumed a fortified egg to provide 10 mcg of Vitamin D3 equivalent to 400 IU of Cholecalciferol, 3 times a week.
The control group received unfortified egg (\~ 43 IU Vitamin D) with the same frequency as the intervention group.
Main Outcomes:
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).
Other Variables:
Blood parameters were taken: total cholesterol, HDL cholesterol, triglycerides, glucose, and hemoglobin.
Anthropometric measurements of weight, height, age.
Morbidity (diarrhea, constipation and respiratory tract infections) was evaluated three times per week and recorded.
Standardized personnel weight the egg consumed before and after breakfast with a food weighing scale.
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.
The 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.
The children's mothers or guardians signed an informed consent letter.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's enrollment of 275 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Instituto Nacional de Salud Publica, Mexico is the lead sponsor of 31 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Dietary Supplement: vitamin D-enhanced egg
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).
Other: Control
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. This ensured that the hens eggs were enhanced with vitamin D achieving a final concentration of approximately 400 IU of vitamin D
Unfortified eggs were used for the control group with a concentration of approximately 43 IU of vitamin D
Serum 25-OH-D
nmol/L
Time frame: At baseline and at 12 weeks of intervention
Serum PTH
pcg/mL
Time frame: At baseline and at 12 weeks of intervention
Insulin
ug/dL
Time frame: At baseline and at 12 weeks of intervention
Weight
kg
Time frame: At baseline and at 12 weeks of intervention
Height
cm
Time frame: At baseline and at 12 weeks of intervention
Total Cholesterol
mg/dL
Time frame: At baseline and at 12 weeks of intervention
Triglicerids
mg/dL
Time frame: At baseline and at 12 weeks of intervention
HDLc
mg/dL
Time frame: At baseline and at 12 weeks of intervention
Glucose
mg/dL
Time frame: At baseline and at 12 weeks of intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto Nacional de Salud Publica, Mexico