Impact of point of care multiple micronutrient

fortification on anemia, iron status and cognitive

development of preschoolers

K.M Nair1, M. Black2, S.Fernandez-Rao1, K. Hurley3, N. Balakrishna1, K.

Radhakrishna, MBBS1, N.Tilton2, G. Reinhart4, Kim Harding5

1National Institute of Nutrition, 2University of Maryland School of Medicine, 3Johns

Hopkins Bloomberg School of Public Health, 4Mathile Institute for the Advancement in

Human Nutrition , 5 The Micronutrient Initiative

Registered at ClinicalTrials.gov (NCT01660958)

• ‘Point-of-care’ food fortification with MNP a novel

alternative to daily supplementation for delivering iron

and other micronutrients with foods

• Variability in the formulation of MNP, target age group,

and settings or context

• Early brain development is also sensitive to built

environment and services.

• Integrating nutrition with child development interventions

may lead to synergistic effects on early child development

that are stronger than single sector interventions.

• India provides an integrated nutrition/child development

(preschool) services through government-sponsored

Integrated Child Development Services.

Rationale

To examines whether preschool-delivered, multiple micronutrient

powder (MNP) fortified meals vs. placebo impact child development

and whether effects vary by preschool quality.

Hypotheses:

The MNP leads to better MN status, development, and growth,

compared to placebo

High Quality AWC s are associated with better development than

Low Quality AWCs.

The effect of the MNP on preschoolers’ development varies by the

quality of the AWC, with stronger effects in High Quality AWCs.

Objectives

Study design:

A cluster randomized, double masked, controlled trial of

MNP/placebo powders nested within low-/high-quality preschools.

Sample size of 76/group, clustered in 22 preschools for moderate

effect size on child development (0.5 SD).

Design

Randomly Selected AWC, n= 22

Eligible AWC Children

n= 336

Baseline

n = 321

Low Quality AWC

n=11

High Quality AWC

n=11

End line

n= 298

MNP

n=77

PLACEBO

n=88

MNP

n=94

PLACEBO

n=67

MNP

n=66

PLACEBO

n=85

MNP

n=85

PLACEBO

n=62

Rated using modified Early Childhood Environment Rating Scale (ECERS) and Home/Preschool Observation of the Environment

(HOME)

MNP/placebo nested within High/Low Quality AWCs (cluster randomization)

• Dewormed

Formulation

MN Amount

Iron (mg) 13

Zinc (mg) 5

Folic acid (µg) 20

Vitamin A (µg) 150

Vitamin C (mg) 20

Vitamin B12 (µg) 0.5

Vitamin B2 (mg) 0.5

Placebo B2 (mg) 0.5

Formulated by the team and supplied by M/s Piramal, Mumbai, India

• 2 scoops (1g and 5 g)

• Instructions printed on

the pack

• 1 g/child mixed with

cooked and cooled food

• Anganwadi worker and

helper were trained

• Record food intake for

each child

Training

• Duration: Six days/week for 6 months

• Weekly supervision by project staff

• AWC staff recorded attendance & meal

consumption

• Compliance (percent meals consumed) 80.1±16.0

(CI: 78.3-81.9)

Results: Baseline Characteristics

No difference in

baseline

characteristics

across groups

Biomarkers Placebo (N=149) MNP (N=167) P

Hb g/dL 11.2 ± 0.15 12.1 ± 0.15 <0.0001

Ferritin µg/L 15.6 ± 1.19 24.3 ± 1.19 <0.0001

sTfR mg/L) 3.2 ± 0.007 2.3 ± 0.007 <0.0001

Mean age 37 ±3.27m Anemia (Hb <11g/dL) 47.8%

Gender, males 48% Moderate (7-10g/dL) 24.1%

Wasted 19.9% Mild (10-11 g/dL) 23.7%

Stunted 40.5% Ferritin < 12 µg/L 42%

Low weight-for-age 46.1% sTfR > 2.5 mg/L 68%

Statistical Analyses: Generalized linear mixed effects regression models accounting for preschool clustering and including preschool quality-by-fortification interactions.

35.1

51

66.4

9.5 7.9

24.5

0

10

20

30

40

50

60

70

Anemia <11 g/dL Ferritin <12 ng/mL sTfR >2.5mg/L

Placebo (N=151) MNP (N=170)

Pe

rce

nta

ge

End line values were adjusted with baseline values and clustering effect

64.3

15.7 19.3

0.7

90.5

7.52 0

0102030405060708090

100

No-anemia Mild Moderate Severe

Placebo MNP

Perc

enta

ge

P<0.0001

No significant change of other micronutrients

Mean Development at Baseline Low Quality

(N=159)

High Quality

(N=157)

p-value MNP

(N=167)

Placebo

(N=149)

p-value

Receptive

Language41.4±0.85 43.3±0.97 0.083 42.5±0.82 42.2±0.85 0.803

Expressive

Language 37.6±1.01 40.3±1.04 0.054 39.3±0.97 38.5±1.02 0.531

Visual

Perception 41.3±1.12 42.8±1.15 0.324 42.6±1.09 41.4±1.13 0.413

Fine Motor 44.0±0.93 46.2±0.96 0.093 45.1±0.92 45.1±0.98 0.997

Inhibitory

Control 2.3±0.33 2.4±0.34 0.744 2.5±0.32 2.1±0.33 0.334

Caregiver -

Behaviour

Rating

23.8±0.36 24.3±0.36 0.261 23.7±0.36 24.3±0.34 0.149

Longitudinal Mixed Models: Effects of treatment (MNP intervention); Differences by

Anganwadi Center Quality; Treatment by AWC Quality interaction; Does treatment vary by

quality of AWC

Development - Interaction for Expressive Language(EL)

20

25

30

35

40

45

50

HQ+MNP HQ+Placebo LQ+MNP LQ+Placebo

Baseline Endline

NS NSM

ean S

tandar

d S

core

s P=.04 P=.05

Low Quality AWC

MNP: Scores Improve

Placebo: Scores Worsen

MNP group scores were higher than placebo

group scores Effect Size=0.4, (CI 0.1, 0.8).

No endline difference HQ AWC and LQ MNP

Similar pattern of significance was

found for

Inhibitory Control (p=0.006)

Caregiver report of child’s behavior

(p=0.01)

2x greater HAZ change in MNP group compared to placebo among non-stunted

children (p=0.03)

NS

Results: No overall effect on growth or morbidity

Conclusions

Adding MNP fortification to preschool meals reduces rates of anemia

and iron deficiency, and reduces disparities in language, inhibitory

control and parent-reported behavior associated with preschool

quality.

Scaling MNP meal fortification and improving preschool quality can

enhance preschoolers’ development and reduce disparities.

The ICDS platform and its supply chain (CDPOs Godown)

Cost of the MNP is 35 paise per child/day

Implications for scaling up