Malnutrition Clinical Trial
Official title:
Investigating the Impact of Moringa Oleifera Leaf Supplementation on Growth, Nutrition, Lactation, and Inflammation in Kenyan Breastfeeding Mothers and Children
Verified date | October 2023 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 4, 2022 |
Est. primary completion date | September 4, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Chulaimbo Sub- County Hospital | Kisumu | |
Kenya | Kombewa County Hospital | Kisumu |
Lead Sponsor | Collaborator |
---|---|
Suzanna L Attia | Fogarty International Center of the National Institute of Health |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Body Weight | Body weight | at baseline and 3 months | |
Secondary | Change in Infant Height | Height (body length) | at baseline and 3 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change in Fecal Neopterin | Fecal neopterin will be measured at baseline and at 3 months. | baseline and 3 months | |
Secondary | Change in Fecal Myeloperoxidase | Fecal myeloperoxidase will be measured at baseline and at 3 months. | baseline and 3 months | |
Secondary | Change in Alpha-1-Antitrypsin | Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months. | baseline and 3 months | |
Secondary | Change in the Prevalence of Diarrhea | Proportion of participants experiencing diarrhea (> 3 watery stools in 24 hours). | 1 and 3 months | |
Secondary | 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 | |
Secondary | Change in Breastmilk Vitamin A | Levels of vitamin A in breastmilk will be measured at the end of the study. | baseline and 3 months |
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