Studies to date on the effects of Moringa oleifera in diabetes and anemia and animal studies that examine the utility of moringa for increased milk and litter yield are of small scale, however high-quality large-scale placebo or case-controlled clinical trials to define the impact on infants of moringa leaf powder consumption by breastfeeding mothers are lacking. Moringa has a traditional and agricultural history of use as a galactagogue; despite this and its incorporation into products such as Mother's Milk Tea© and placement on NIH LactMed Lactation Database, this property has not been studied in large clinical trials nor in populations dependent on breastmilk such as in Kisumu, Kenya. This study will improve and add to existing knowledge of moringa's effect on human breastmilk and will provide novel information on the effect of moringa supplementation to lactating mothers on their infant's intestinal inflammation and health. After trial registration, the study was modified to include infant follow up to 18 months for some measures and the children's groups were removed. Although the study was modified to an 18 month follow up, the data were not able to be collected. Further understanding of the acceptability of moringa leaf in a staple food of porridge and more the effect of moringa supplementation on infant and childhood growth, nutrition, and intestinal and systemic inflammation may translate in the future to the cultivation of moringa at the community or household level as an effective resource for the improvement of childhood undernutrition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
Mothers and children will receive porridge with placebo.
Kombewa County Hospital
Kisumu, Kenya
Chulaimbo Sub- County Hospital
Kisumu, Kenya
Change in Body Weight
Body weight
Time frame: at baseline and 3 months
Change in Infant Height
Height (body length)
Time frame: at baseline and 3 months
Change in Mid-Upper Arm Circumference
Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months. Change from baseline to 3 months reported
Time frame: baseline and 3 months
Change in Vitamin A
Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months..
Time frame: 3 months
Change in CRP Levels
C-reactive protein (CRP) will be used to measure inflammation at baseline and monthly to 3 months. Change from baseline to 3 months reported. Negative values are considered a better outcome.
Time frame: baseline and 3 months
Change in the Soluble Transferrin Receptor
The soluble transferrin receptor (sTFR) will be used to evaluate anemia at baseline and monthly to 3 months. Change from baseline to 3 months reported.
Time frame: baseline and 3 months
Change in Fecal Neopterin
Fecal neopterin will be measured at baseline and at 3 months.
Time frame: baseline and 3 months
Change in Fecal Myeloperoxidase
Fecal myeloperoxidase will be measured at baseline and at 3 months.
Time frame: baseline and 3 months
Change in Alpha-1-Antitrypsin
Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.
Time frame: baseline and 3 months
Change in the Prevalence of Diarrhea
Proportion of participants experiencing diarrhea (\> 3 watery stools in 24 hours).
Time frame: 1 and 3 months
Change in Breastmilk Volume
Breastmilk volume will be assessed from 24 hour breast pumping or hand expression or weighing the infant before and after feeding for 24 hours.
Time frame: at enrollment and at 3 months
Change in Breastmilk Vitamin A
Levels of vitamin A in breastmilk will be measured at the end of the study.
Time frame: baseline and 3 months
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