Vitamin D3-enhanced Eggs in Preschool Children
Condition: Vitamin D Deficiency; 25-Hydroxyvitamin D3 Deficiency, Selective
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      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:

        1. to evaluate the efficacy of fortified egg with vitamian D3 on serum concentrations of
           25-hydroxyvitamin D3

        2. and to evaluate parathyroid hormone (PTH) in children aged 12 to 60 months of age.

             -  Children would be given for breakfast fortified egg/non-foritfied egg three times
                per week for 12 weeks.

             -  Blood samples will be taken at baseline and at the end of study.

             -  Anthropometric meassurements weight /height will be taken at baseline and at end of
                study.
    

Detailed description: 
      1. 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.

        2. 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.

        3. 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.

        4. 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.

        5. 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.

        6. 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.

        7. 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.

        8. Ethical considerations:

      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.
    

Intervention name(s): vitamin D-enhanced egg; Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double Blind field trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D3; enhanced egg; Vitamin D3-enhanced egg; 25-Hydroxyvitamin D3 Deficiency; supplementation; Mexico; Children