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Indian Coalition for Control of Iodine Deficiency Disorders, New Delhi and Centre for Community Medicine All India Institute of Medical Sciences, New Delhi 1 Iron Fortified biscuits as a vehicle to improve Iron status of primary school study children of East Delhi : A cluster randomized triple blind controlled trial

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Page 1: Iron Fortified biscuits as a vehicle to ... - britannia.co.inbritannia.co.in/britannia-nutrition-foundation/... · Nutrition Profile of Iron Fortified Tiger Glucose biscuits used

Indian Coalition for Control of Iodine Deficiency Disorders, New Delhi and

Centre for Community MedicineAll India Institute of Medical Sciences, New Delhi

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Iron Fortified biscuits as a vehicle to improve Iron status of primary school study children of East Delhi :

A cluster randomized triple blind controlled trial

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In Collaboration..

East Delhi Municipal Corporation (EDMC), Delhi Study children, parents, teachers and support staff of EDMC schools

Indian Coalition for Control of Iodine Deficiency Disorders (ICCIDD), Delhi

All India Institute of Medical Sciences (AIIMS), New Delhi

Centre for Community Medicine (CCM)

Department of Psychiatry

Department of Hematology

Department of Pediatrics

Department of Biostatistics

Health, Education and Awareness League (HEAL)Foundation

Britannia Nutrition Foundation (BNF)

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Why biscuits as a vehicle for Iron fortification?

Acceptable and palatable

Available

Affordable

Hygienic

Ready to eat

Easy to transport, store and distribute

No side effects

Existing norm across age groups 3

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AIM

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To assess the effectiveness of Iron fortification (using biscuits as a vehicle) on hemoglobin and anemia

prevalence in school age children of East Delhi Municipal Corporation schools

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MATERIAL AND METHODS

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Study Setting

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• Primary schools of East Delhi Municipal Corporation (EDMC), Delhi

New Ashok Nagar

Vashundhara

Enclave

Khichripur

Chajjupur

Gamri

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Study design:– Cluster randomized triple blind controlled trial

Study Duration:

- Nine Months ( from 15th August’2013 to 15th May’2014)

Study population: – study children aged 7-9 years studying in 2nd and 3rd grade

of EDMC primary schools, Delhi

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Trial Profile

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620 study children assessed for eligibility

382 children RANDOMIZED

Iron Fortified(n=189)

Non Fortified n=(193)

Severe anemia: 74Age ( <7 or >9): 159Chronic absent : 5

Excluded= 238

28 (14.8%) lost to follow up

28 (14.5%) lost to follow up

Base line EvaluationSocio- demography status of family, 24 hr Dietary intake , Height , Weight and Hemoglobin

161 included in analysis165 included in analysis

Intervention 6 months

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Time line of study activities

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Activity Aug,13 Sept,13 Oct,13 Nov, 13 Dec, 13 Jan,14 Feb,14 Mar,14 Apr,14 May,14

Study started 15

thEnrollment 28

th9

thStudy duration: 185 days

* Excluding holidays

Intervention days : 129

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*Nutrition Information per serving of biscuit

Nutrient Fortified Biscuit Non fortified Biscuit

Carbohydrates (g) 12 12**Sugars (g) 4 4Proteins (g) 1 1Fat (g) 2 2

Energy (Kcal) 70 70Figures based on calculated values

(Ref:*NIN; **USFDA norm)Iron (mg) 20

Nil

Vitamin A (mcg) 150Calcium (mg) 150Vitamin D (mcg) 1.5Riboflavin (mg) 0.5Vitamin B6 (mg) 0.8Vitamin B12 (mcg) 0.3Folic acid (mcg) 60

Biscuit CompositionPer serving: 4 biscuits

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RESULTS

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Baseline characteristics of study children in the study arms

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Variable Iron fortified (N=189)Non fortified

(N=193)

Age (Yrs)(Mean ± SD)

7.9 (0.5) 7.9 (0.5)

13

P=0.7

Mean age of study children

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Prevalence of anemia among study children

14P=0.42

50.8 50.3

0

10

20

30

40

50

60

70

80

90

100

Pre

vale

nce

of

ane

mia

(%

)

Iron fortified Non Fortified

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Prevalence of Iron Deficiency Anemia among study children

15

27

31.1

24

25

26

27

28

29

30

31

32

Pe

rce

nta

ge

P=0.54

Hb<11.5g/dl

Iron fortified Non Fortified

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CHANGE IN STUDY VARIABLESPOST INTERVENTION

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1

0.3

0

0.2

0.4

0.6

0.8

1

1.2C

han

ge in

hem

ogl

ob

in

(g/d

l)

Change in hemoglobin level post intervention

P=0.001

95 %CI; 0.7 to 1.2

95 %CI;0.1 to 0.5

Median intervention days: 92

Iron fortified Non Fortified

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Change in hemoglobin by baseline anemiastatus in Iron fortified group

(95 %CI 1.0 to 1.5)

(95 %CI 1.7 to 2.7)

0.3

1.2

2.2

0

0.5

1

1.5

2

2.5

No anemia Mild anemia Moderate anemia

Incr

eas

e in

me

an h

em

ogl

ob

in

leve

l (g

/dl)

Hb 8-10.9 g/dlHb 11- 11.4 g/dlHb ≥ 11.5g/dl

(95 %CI 0.04 to 0.6)

P=0.001

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Reduction in prevalence of anemiapost intervention

41

5.5

0

5

10

15

20

25

30

35

40

45

50

Ab

solu

te r

ed

uct

ion

in

an

em

ia p

reva

len

ce

P=0.001

95 %CI 33.4 to 48.6

95 %CI 2 to 9

Iron fortified Non fortified

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Summary

Iron fortification using biscuits as a vehicle among school study children resulted in decreasein prevalence of anemia (as compared to baseline) by 79 %

Effectiveness of biscuits to improve hemoglobin found in this study is consistent with meta analysis results ( 1 g/dl;95 %CI;0.7 to 1.2 Vs. 0.42gdl 95% CI0.28 to 0.56)

Plausible analysis confirmed study children with moderate anemia at baseline experienced greater change as compared to mild anemic study children in hemoglobin level.

Iron fortified biscuits is effective intervention

— Reduce anemia

— Increase hemoglobin

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Strengths and limitations

Representative sample of school study children chosen

High compliance (72%)

Low drop out rate

Lack of significant difference in drop out

Baseline characteristics reasonably comparable

Non interference with existing mid day meal program or food intake by study children

Short duration of intervention

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What this adds to existing evidence?

School based fortification program is a feasible approach to reduce Iron deficiency anemia

among study children

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Recommendations

Biscuits can be used as a potential vehicle for future fortification program to target school study children

Larger study exploring the use of biscuits as a vehicle for fortification of other micronutrient should be explored

Future fortification program using biscuits as a vehicle should explore the cost effectiveness of this intervention

Additional information for dietary practices and acceptability of other fortification vehicle can be explored by future qualitative studies

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Conclusion

Iron fortification using biscuits as a vehicle is an effective strategy to address Iron deficiency

anemia among school age study children

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Nutrition Profile of Iron Fortified Tiger Glucose biscuits used in Britannia, AIIMS-EDMC intervention and Iron Fortified Tiger Choco

Cookies for Akshaya Patra Foundation’s (APF) initiative

NutrientsAIIMS-EDMC

intervention study

RDA : 7-9 Years (NIN -2010)

Percent RDA AIIMS-EDMC intervention

study

Tiger Choco cookies (APF) Percent RDA Tiger

Choco cookies (APF)

4 Biscuits/serving 4 Biscuits/serving

Iron(mg) 2016

125 8 50

Folic acid(mcg) 60120

50 60 50

Vitamin B1 NA0.8

NA 0.4 50

Riboflavin(mg) 0.51

50 NA NA

Vitamin B6(mg) 0.81.6

50 0.8 50

Vitamin B12(mcg) 0.30.2-1 30-150

0.5 50-150

Calcium(mg) 151600

25

NA NAVitamin A (mcg) 152

60025

Vitamin D (mcg) 1.5

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Thank you

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