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临床试验/CTRI/2024/11/077369
CTRI/2024/11/077369尚未招募不适用

To study the effect of a new diet in terms of weight gain per day, designed to supplement the calorie and protein requirements in a SAM child

Dr NEHAL ATHREYI R1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To study the effect of a new diet in terms of weight gain per day, designed to supplement the calorie and protein requirements in a SAM child.

研究概览

简要总结

BACKGROUND:

The cost of F-100, when given at 10ml/kg/2nd hourly amounting to 150ml/kg/day comes to Rupees 6.25/kg/day.

 The intervention is called ‘MENOLLI MALT’ which is designed using locally available ingredients which is affordable and culturally acceptable by a poor household ie Rupees 3/kg/day.’

  The RDA in a SAM child is as follows:

FLUID

200ml/kg/day

|CALORIES

150-220kCal/kg/day

|PROTEIN

4-6g/kg/day

 To provide the above mentioned nutrition in the appropriate quantity, I have designed a new diet which contains fourteen ingredients out of which eleven ingredients can be sprouted, dried, powdered(to enhance the nutritive benefits) and stored.

MONITORING is done by daily weight monitoring and the time taken to achieve discharge criteria

  

   CALORIES 4 (kCal)

PROTEIN4

(g)

COST *

per 100g (Rupees)

Quantity to be added (g)

ADDITIONAL NUTRITIVE VALUE

|GREEN GRAM

30

3

9.3

100

  |FOXTAIL MILLET(KANGNI)

376

12

2.4

100

  |MATKI SEED

350

21

4.8

100

  |WHEAT

339

14

6

100

  |BLACK CHANNA

280

20

6

100

selenium

|JOWAR

376

12

7

100

  |PEAS

80

7

7

100

  |FENUGREEK SEEDS

333

26

1

10

  |PEARL MILLET (BAJRA)

376

12

7

100

Carotene

|SOYA

380

40

9

100

  |GROUNDNUT

567

26

16

100

50g healthy fats

|SABU DANA

358

0.2

7

100

  |BARLEY

352

9.9

2

100

  |MAIZE

96

4.5

5

100

  |       | 4293

208

90

1310

  |       |       |RDA in SAM

      |FLUID

200ml/kg/day

     |CALORIES

150-220kCal/kg/day

 45g powder/kg/day

9 tsp/kg/day

  |PROTEIN

4-6g/kg/day

     |       |1Tsp=5g Jaggery

17.5kCal

4.4g

    |15g Jaggery in 100ml water

 *COST is estimated by using the local market prices.

  DIET details

Name: MENOLLI MALT

Quantity of each ingredient: 100g (Except Fenugreek= 10g)

Total quantity of the preparation : 1310g

Quantity of the powder required for 1kg child= 45g/day (to provide 150kCal)

Cost of the powder : Rupees 3/kg/day

    METHOD OF PREPARATION : 100g of each ingredient is taken, they are  sprouted(except Sabu Dana, Barley, Maize), sun dried and ground. Roasting increases the shelf life. Taking 1Tsp=5g, we need about 45g of the powder per kg of the child and hence 9tsp/kg. With fluid requirement being 200ml/kg, we take 250ml water and add 9tsp of the malt powder and 2tsp of Jaggery (for taste and Iron source) and bring to a boil, which will take a maximum of about 10minutes. Then it is cooled and fed at a temperature accepted by the baby.

 FREQUENCY OF FEED:  The baby can be fed as per demand and the number of feeds titrated according to the quantity of powder required per day.

 BENEFITS OF THE MALT:

1.         Multinutrient rich including vitamins and trace elements which are mostly deficient in SAM children.

2.         Locally available ingredients

3.         Easy to prepare, requires maximum of 15-20minutes per day.

4.         Good shelf life. Once powder is made, it can b

5.         Low cost: Rupees 3/kg/day. Which on an average amounts to Rupees 450 for a 5kg child per month.

 Criteria to be fulfilled at the time of discharge- as per NRC protocol

●      return of appetite

●      no episodes of hypoglycaemia (metabolically stable)

●      reduced or disappearance of all oedema

Outcome

●      Discharge

PURPOSE OF THE STUDY

to study if a diet which is prepared using locally available ingredients which is culturally more acceptable is as good as F-100 diet in the management of SAM

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • All the children registered in MTC ward, whose complication has been managed and are entering the Rehabilitation phase of SAM management.

排除标准

  • All those who refuse to consent 2) Critically ill patients 3) Secondary SAM 4) History of food allergy(Gluten, Peanut, etc).

结局指标

主要结局

To study the effect of a new diet in terms of weight gain per day, designed to supplement the calorie and protein requirements in a SAM child.

时间窗: Daily monitoring for weight

次要结局

  • To look for the development any intolerance in the form of vomiting, loose stool or sepsis upon supplementation of the new diet.(Daily monitoring for intolerance)

研究者

发起方
Dr NEHAL ATHREYI R
申办方类型
Other [Primary investigator ]
责任方
Principal Investigator
主要研究者

Dr NEHAL ATHREYI R

RNT medical college

研究点 (1)

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