MannaPack™ Potato Clinical Trial
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Transcript of MannaPack™ Potato Clinical Trial
OUTLINE OF PRESENTATION
• Introduction
• Background
• Stakeholders
• Methods
• Results
• Limitations
• Conclusions
• Recommendations
BACKGROUND: South Africa• 49.32 million (SSA 2009)
• 40% live in poverty (Cunnan & Maharaj, 2000:669, SA Govt, 2001)
• 2.5% hungry (1.23 million people household food insecurity) (SSA 2009)
• 20% of SA children stunted
• 33.3% iron deficiency anaemia in children and women
• 45.3% children at risk of zinc deficiency
• 10% of children overweight (Labadarios et al., 2008)
• 16.6% HIV and AIDS prevalence (WHO Stats, 2008)
INTRODUCTION• Diarrhea = one of the top killers of
children around the world
• Solution = medication or oral rehydration fluids
INTRODUCTION• FMSC - new product, MannaPack™ Potato
(MPP) to provide a “first food” in response to diarrhea
Dehydrated potato granules (resistant starches) Lecithinated soy flour (protein source) Gum arabic (soluble fiber) Vitamins and minerals Mild sweet potato flavoring
• Reduce the impact of diarrhea and maintain
the gut during diarrhea and recovery.
MAIN AIM
Overall purpose of the project was to
document the actual impact and
acceptability of MannaPack™ to
reduce the impact and support resolution
of the symptom of chronic and acute diarrhea.
SPECIFIC OBJECTIVES
Assess the acceptability of
MannaPack™ in a setting that provides care and treatment for children with diarrhea.
Assess the impact of MannaPack™ on
the quality and quantity of acute and chronic diarrhea in a community setting.
PROJECT METHODS
1. Planning• Ethics approval (M080365) • Strategic participatory planning workshop with
all stakeholders in South Africa (SA)• Two crèches in the Vaal region identified (control
group)• SOS village for HIV/AIDS-affected orphans in
Qwa-Qwa (experimental group). • Consent• Training of data enumerators and monitors
PROJECT METHODS
2. Measurements• Diarrhea questionnaire - baseline + 6 weekly• Sensory questionnaire – baseline and end
PROJECT METHODS
2. Measurements• Weight and height, handgrip, skin tenting
& nail blanching – baseline + 6 weeks
QWA-QWA BACKGROUND
• 5 people per household (hh)• 89.9% of caregivers unemployed• 67.4% of partners unemployed• 59.1% of hh < R 1000 (US$133) pm• 51.0% hh food insecurity
• 4.9 people per hh• 94.1% of caregivers
unemployed• 80.1% of partners
unemployed• 58.3% of hh < US$133
pm• 53.0% hh food insecurity
VAAL REGION BACKGROUND
LIMITATIONS• Questionnaires not tested for SA but for
Zimbabwe only although in the same region
• Diarrhea not a public health problem in
SA – small sample size
• 2010 World Cup
Beneficiary profilewho completed the study
Children between the ages 2 to 13 years of age
• Experimental group consisted of 29 girls and 32 boys with overall mean age of 6.2 years
Control group was 27 girls and 22 boys with overall mean age of 3.5 years
• 2010 World Cup
RESULTSVariable Experimental group (n=63) Control group (n=49)
Baseline Follow-up Significance of change between
baseline and follow-up
(p)
Baseline Follow-up Significance of change between
baseline and follow-up
(p)
Age 6.2±3.6 6.4±3.5 3.4±1.2 3.4±1.1Weight (kg) 21.9±8.8 22.2±9.1 0.002 15.07±2.54 15.06±2.56 0.444
Height (m) 1.14±0.21 1.15±0.21 0.047 1.04±0.27 1.05±0.27 0.083
Skin tenting (seconds)
1.0±0.0 1.0±0.0 0.145 3.0±0.6 3.2±0.6 0.133
Nail blanching (seconds)
3.9±0.9 3.6±0.7 0.004 3.1±0.6 3.1±0.6 1.000
Handgrip right hand
7.5±4.2 7.4±4.1 0.400 - -
Handgrip left hand 7.0±4.4 7.1±4.2 0.681 - -
RESULTS: STUNTING (EXPERIMENTAL)
Classification Girlsn= (%)
Boysn= (%)
Total groupn=61 (%)
Baseline
Severely stunted
3.4 6.3 4.9
≥-3<-2 SD Stunted 10.3 6.3 8.2
Girlsn=25 (%)
Boysn=21 (%)
Total groupn=46 (%)
At the end of the intervention (Follow-up)
<-3 SD Severely stunted
3.4 6.3 4.9
≥-3<-2 SD Stunted 10.3 6.3 8.2
RESULTS: STUNTING (CONTROL)
Classification Girlsn=27 (%)
Boysn=22 (%)
Total groupn=49 (%)
Baseline
<-3 SD Severely stunted
0 5.9 2.3
≥-3<-2 SD Stunted 11.5 17.6 14.0
Girlsn=25 (%)
Boysn=21 (%)
Total groupn=46 (%)
At the end of the intervention (Follow-up)
<-3 SD Severely stunted
0 5.9 2.3
≥-3<-2 SD Stunted 11.5 17.6 14.0
RESULTS: UNDERWEIGHT (EXPERIMENTAL)
Classification Girlsn=25 (%)
Boysn=23 (%)
Total groupn=48 (%)
Baseline
<-3 SD Severely underweight
0 4.5 2.1
≥-3<-2 SD Underweight 11.5 4.5 8.3
Girlsn=25 (%)
Boysn=21 (%)
Total groupn=46 (%)
At the end of the intervention (Follow-up)
<-3 SD Severely underweight
0 0 0
≥-3<-2 SD Underweight 7.7 0 4.2
RESULTS: UNDERWEIGHT (CONTROL)
Classification Girlsn=25 (%)
Boysn=23 (%)
Total groupn=48 (%)
Baseline
<-3 SD Severely underweight
3.7 0 2.0
≥-3<-2 SD Underweight 3.7 4.5 4.1
Girlsn=25 (%)
Boysn=21 (%)
Total groupn=46 (%)
At the end of the intervention (Follow-up)
<-3 SD Severely underweight
3.7 0 2.0
≥-3<-2 SD Underweight 3.7 4.5 4.1
CONCLUSIONS• MannaPackT consumption results
indicated a minority consuming the product for the whole week.
• A significant improvement was observed for underweight after the intervention.
• Impact of the MannaPackTM on the nutritional status of the experimental group very clear.
• This was not observed in the control group.
CONCLUSIONS
• Incidence and severity of diarrhea significantly reduced in the experimental group as the study progressed.
• Control group remained largely
unchanged.
• MannaPackTM contributed to the
reduced incidence and prevalence of diarrhea in the experimental group.
ACCEPTABILITY RESULTS
• Mashed potatoes not commonly consumed by the low-income groups in South Africa.
• MannaPackTM not very acceptable at baseline.
• Liked the MannaPackTM towards the end of the study.
RECOMMENDATIONS
• MannaPackTM can be effectively used as a relief food in emergency situations where both diarrhea and/or acute food shortage exist.
• Can complement the already successful commodities like CSB and WSB in the USAID title II programmes.