跳至主要内容
临床试验/CTRI/2018/03/012440
CTRI/2018/03/012440已完成4 期

A study of demographic characteristics and impact of Medical Nutrition Therapy in children with severe wasting in the age group 5-10 years

UNICEF1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2015年4月13日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
UNICEF
入组人数
104
试验地点
1
主要终点
2) To assess the rate of weight gain.

研究概览

简要总结

The study was carried out in the paediatric department of a large tertiary referral centre from April 2015 to November 2016. All admitted children were subjected to anthropometry i.e. weight and height. BMI was calculated and scrutinized as per WHO standard growth charts 2007. The screened patients were enrolled into study in accordance with the inclusion criteria in the aforesaid study period after informed consent obtained from the parents/guardian. A total of 113 patients were enrolled into the study. They were divided into cases (n=58) & controls (n=55). After obtaining the consent they were subjected to an appetite test. Medical Nutrition Therapy was prepared in the production unit indigenously.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

MNT Recipe

Ingredients

% weight

|Peanut paste

25

|Skimmed milk powder

24

|Powdered sugar

28

|Soybean oil

20.8

|Micronutrient mix

1.6

|Emulsifiers

0.6

  Pack size of 92 grams giving 515 kcal and 13.6 gm proteins and 1.47 gm weight of micronutrients as per WHO specifications.

The appetite test look up charts is attached below annexure number 6.

Subjects were enrolled after passing the appetite test and a detailed history,clinical examination is carried out in a predesigned pre tested Performa as attachedin the annexure number 4.

As per WHOUNICEF 2009 protocol, cases were given Medical Nutrition Therapy for a period of 8 weeks alongwith nutritional counselling (annexure 5).The controls were given only nutritional counselling.

Nutritional counselling was structured on the following principles.

a)    Minimum Meal Frequency.

b)    Minimum Dietary Diversity.

c)    Emphasis on family based low cost high protein and energy yielding food appropriate to the community and socioeconomic background.

  Detailed history of the patients was obtained.A complete clinical examination of patients at the time of admission including vitals, general examination, a detailed anthropometry with WHO classification for malnutrition and systemic examination was done. These details were filled in predesigned case record form.

The detailed anthropometry wasdone as follows. The weight was taken using standard electronic weighing scale. The height for children was taken using a stadiometer. Body mass index was calculated using formula: weight in kg/ (height in metre)2. Malnutrition was classified according to the WHO guidelines taking only BMIparameter between five years to ten years. BMI less than three standard deviations were designated as Severe Thinness. Those falling between two and three standard deviations below median were designated as Thinness.

The cases received Medical Nutrition Therapy as per WHO protocol for RUTF (ready to use therapeutic food).

The subjects were followed up every weekly for a period of 8 weeks (duration of MNT received). A detailed anthropometric examination along with clinical examination & nutritional counselling were given to subjects at each visit during follow up.

All these details were recorded in a case record form designed for the study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • •Children between 5-10 yrs referred to OPD &/or admitted with Severe Thinness i.e. BMI < -3 SD as per BMI charts by WHO.

排除标准

  • •1.Children with chronic illnesses 2.Inability to take orally 3.Children already on any nutritional supplements
  • •Failed appetite for 3 consecutive days.

结局指标

主要结局

2) To assess the rate of weight gain.

时间窗: 1 week, 2week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week

3) To assess the nutritional outcome at the end of 8 weeks.

时间窗: 1 week, 2week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week

1) TO assess the efficacy of MNT.

时间窗: 1 week, 2week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week

次要结局

  • To assess the nutritional outcome at the end of 8 weeks.(1 week, 2 week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week)

研究者

发起方
UNICEF
申办方类型
Other [Non-government organisation]

研究点 (1)

Loading locations...

相似试验