Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children

Study Overview
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Brief Summary
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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.

Official Title
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Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children

Conditions
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Malnutrition, Wasting, Growth Failure

Intervention / Treatment
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* Dietary Supplement: Moringa oleifera (high dose)
* Dietary Supplement: Moringa oleifera (low dose)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: lactating women at least 18 years of age and their exclusively breastfed infants within 14 days of delivery. children 6-59 months of age who eat food Exclusion Criteria: regular maternal consumption of moringa receipt and consumption of food supplementation program inability to feed orally or refusal to eat moringa or placebo porridge for infants, prematurity (<36 weeks gestational age) for infants, significant congenital disease for infants, inability to feed orally
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactating Mothers (Moringa)<br>Lactating mothers. | Dietary Supplement: Moringa oleifera (high dose)<br>* Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.<br>|
| Experimental: Breastfeeding Infants (Moringa)<br>Breastfeeding infants from lactating mothers | Dietary Supplement: Moringa oleifera (high dose)<br>* Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.<br>|
| Experimental: Children (Moringa)<br>Children from 6-59 months of age. | Dietary Supplement: Moringa oleifera (low dose)<br>* Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.<br>|
| Placebo Comparator: Lactating Mothers (placebo)<br>Lactating mothers. | Dietary Supplement: Placebo<br>* Mothers and children will receive porridge with placebo.<br>|
| Placebo Comparator: Breastfeeding Infants (placebo)<br>Breastfeeding infants from lactating mothers | Dietary Supplement: Placebo<br>* Mothers and children will receive porridge with placebo.<br>|
| Placebo Comparator: Children (placebo)<br>Children from 6-59 months of age. | Dietary Supplement: Placebo<br>* Mothers and children will receive porridge with placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | Body weight | at baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Infant Height | Height (body length) | 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 | 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.. | 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. | 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. | baseline and 3 months | 
| Change in Fecal Neopterin | Fecal neopterin will be measured at baseline and at 3 months. | baseline and 3 months | 
| Change in Fecal Myeloperoxidase | Fecal myeloperoxidase will be measured at baseline and at 3 months. | baseline and 3 months | 
| Change in Alpha-1-Antitrypsin | Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months. | baseline and 3 months | 
| Change in the Prevalence of Diarrhea | Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours). | 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. | 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. | baseline and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moringa oleifera, supplementation