CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Moringa oleifera (high dose) +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04587271
NCT04587271N/ACompleted

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

Suzanna L Attia·interventional·Posted Oct 14, 2020·Updated Nov 22, 2023

In Brief

A clinical study evaluating Moringa oleifera (high dose), Moringa oleifera (low dose), and 1 other intervention for Malnutrition and 2 related conditions. Completed, enrolled 100 participants across 2 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKenya

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 14, 2020
Enrollment StartJul 21, 2021
Primary CompletionSep 4, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.7 years ago

Interventions

Moringa oleifera (high dose)dietary

Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.

Moringa oleifera (low dose)dietary

Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.

Placebodietary

Mothers and children will receive porridge with placebo.