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临床试验/NCT06096194
NCT06096194已完成不适用

Effect of the Consuption of Vitamin D3-enhanced Eggs on Serum 25-hydroxivitamin D[(25-OH)D3] and Parathyroid Hormone (PTH) in Preschool Children

Instituto Nacional de Salud Publica, Mexico2 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2018年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
275
试验地点
2
主要终点
Serum 25-OH-D

研究概览

简要总结

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.

详细描述

  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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Two types of eggs. Control egg and fortified egg (vitamin D3-enhanced egg), only the researcher in charge of eggs production was not blinded

入排标准

年龄范围
12 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children of either sex, from 12 to 59 months of age who attend take care SEDESOL centers
  • Children who consume eggs within their usual diet at least 5 times per month
  • Childrens whose parents or legal guardian agree to participate in the study and sign an informed consent letter

排除标准

  • Children with an egg allergy
  • Chldren with hypersensitivity to vitamin D
  • Children who have taken vitamin D supplements in the past month

结局指标

主要结局

Serum 25-OH-D

时间窗: At baseline and at 12 weeks of intervention

nmol/L

次要结局

  • Serum PTH(At baseline and at 12 weeks of intervention)

研究者

发起方
Instituto Nacional de Salud Publica, Mexico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Flores-Aldana

Mario Flores-Aldana, MD, PhD Nutrition Surveillance, Director

Instituto Nacional de Salud Publica, Mexico

研究点 (2)

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