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Effect of Indigenous Ready to use Therapeutic Food i.e. Medical nutrition therapy on children suffering from severe wasting in age group of 5-10 years.

Phase 4
Completed
Conditions
Severe Thinness
Registration Number
CTRI/2018/03/012440
Lead Sponsor
UNICEF
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
104
Inclusion Criteria

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

Exclusion Criteria
  • 1.Children with chronic illnesses 2.Inability to take orally 3.Children already on any nutritional supplements 4.
  • Failed appetite for 3 consecutive days.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2) To assess the rate of weight gain.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.1 week, 2week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week
1) TO assess the efficacy of MNT.1 week, 2week, 3 week, 4 week, 5 week, 6 week, 7 week, 8 week
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

Nutritional Rehabilitation, Research and Training Centre

🇮🇳

Mumbai, MAHARASHTRA, India

Nutritional Rehabilitation, Research and Training Centre
🇮🇳Mumbai, MAHARASHTRA, India
Dr Alka Jadhav
Principal investigator
9769765309
alkaraja1@rediffmail.com

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