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临床试验/NCT03551613
NCT03551613已完成不适用

Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children

Ain Shams University0 个研究点目标入组 75 人开始时间: 2016年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
主要终点
anthropometric measurements

研究概览

简要总结

This study was a randomized single blinded case control prospective intervention study.

详细描述

Fifty infants and children of both sexes, aged 6 months to 3 years, with malnutrition were consecutively recruited from the Nutrition Clinic of the Pediatric Hospital, Ain Shams University.

These patients were randomly assigned following a simple randomization procedure (computerized random numbers) to either the honey group (group 1) or the malnourished control group (group 2) with a 1:1 allocation ratio. Each group consisted of 25 patients.

An additional 25 healthy infants and children with the same age range and of both sexes were recruited from the outpatient pediatric clinic of Ain Shams University, Egypt as a healthy control group (group 3).

The inclusion criteria was in whom the under nutrition is caused by inadequate energy intake, while the exclusion criteria included markedly ill patients, and children with chronic or severe systemic illness or malabsorption disorders, chromosomal aberrations, inborn errors of metabolism and cerebral palsy.

History taking with special emphasis on the dietetic history, history of any disease that might interfere with the nutrient intake or their use by the body and history of any acute or chronic illness. And full body Examination which include anthropometric measurements weight, height and mid arm circumference.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
6 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • simple malnutrition

排除标准

  • cancer, sepsis, endocrine disorders, neurologic disorders, diabetes mellitus, heart failure renal failure liver cell failure. malabsorption disorders, chromosomal aberrations, inborn errors of metabolism cerebral palsy .

结局指标

主要结局

anthropometric measurements

时间窗: 2 month duration of honey supplementation

effect of honey on growth assessed by anthropomerty

serum leptin

时间窗: 2 month duration of honey supplementation

effect of honey supplement on serum leptin in malnourished patients

次要结局

  • frequency of infection and total caloric intake in the honey group(2 month duration of honey supplementation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

yasmin gamal el gendy

Lecturer of Pediatrics

Ain Shams University

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