Trial Outcomes & Findings for Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children (NCT NCT04587271)
NCT ID: NCT04587271
Last Updated: 2023-11-22
Results Overview
Body weight
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
at baseline and 3 months
Results posted on
2023-11-22
Participant Flow
After trial registration, the children's groups were removed so no children were enrolled in the study
Participant milestones
| Measure |
Lactating Mothers (Moringa)
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Children (Moringa)
Children from 6-59 months of age.
Moringa oleifera (low dose): Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
Children (Placebo)
Children from 6-59 months of age.
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
0
|
25
|
25
|
0
|
|
Overall Study
COMPLETED
|
23
|
23
|
0
|
22
|
23
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Lactating Mothers (Moringa)
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Children (Moringa)
Children from 6-59 months of age.
Moringa oleifera (low dose): Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
Children (Placebo)
Children from 6-59 months of age.
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
0
|
2
|
2
|
0
|
|
Overall Study
Caregiver brought child to visits
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
Baseline characteristics by cohort
| Measure |
Lactating Mothers (Moringa)
n=25 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=25 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=25 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=25 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 6 • n=5 Participants
|
0.04 years
STANDARD_DEVIATION 0.02 • n=7 Participants
|
27.8 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
.05 years
STANDARD_DEVIATION .02 • n=4 Participants
|
13.8 years
STANDARD_DEVIATION 4.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
100 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Kenya
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
25 participants
n=4 Participants
|
100 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: at baseline and 3 monthsBody weight
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=23 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=23 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=22 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=23 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Body Weight
|
365 g
Standard Deviation 3102
|
2.5 g
Standard Deviation 0.9
|
-470 g
Standard Deviation 2988
|
2.5 g
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: at baseline and 3 monthsPopulation: Height was not measured in the mothers
Height (body length)
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=23 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=23 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Infant Height
|
9.1 cm
Standard Deviation 2.1
|
9.3 cm
Standard Deviation 1.7
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: change in MUAC was not measured in the infants
Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months. Change from baseline to 3 months reported
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=23 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=22 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Mid-Upper Arm Circumference
|
-1.7 cm
Standard Deviation 1.5
|
-1.6 cm
Standard Deviation 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 1 additional participant in the placebo group of mothers provided blood work (23 total as opposed to 22 from the participant flow section); Unable to get blood samples from 1 pair in the Moringa group (22 total as opposed to 23 from the participant flow section)
Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months..
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=22 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=22 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=23 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=23 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Vitamin A
|
-0.29 mcmol/L
Standard Deviation 0.50
|
0.08 mcmol/L
Standard Deviation 0.48
|
-0.23 mcmol/L
Standard Deviation 0.69
|
0.09 mcmol/L
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 1 additional participant in the placebo group of mothers provided blood work (23 total as opposed to 22 from the participant flow section); Unable to get blood samples from 1 pair in the Moringa group (22 total as opposed to 23 from the participant flow section)
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.
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=22 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=22 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=23 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=23 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in CRP Levels
|
-3.5 mg/L
Standard Deviation 11.6
|
2.3 mg/L
Standard Deviation 6.3
|
-5.3 mg/L
Standard Deviation 8.1
|
8.8 mg/L
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 1 additional participant in the placebo group of mothers provided blood work (23 total as opposed to 22 from the participant flow section); Unable to get blood samples from 1 pair in the Moringa group (22 total as opposed to 23 from the participant flow section)
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.
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=22 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=22 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=23 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=23 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in the Soluble Transferrin Receptor
|
-0.1 mg/L
Standard Deviation 2.8
|
2.5 mg/L
Standard Deviation 2.1
|
-1.3 mg/L
Standard Deviation 2.6
|
1.8 mg/L
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants.
Fecal neopterin will be measured at baseline and at 3 months.
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=21 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=21 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=22 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=22 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Fecal Neopterin
|
21.56 nmol/L
Standard Deviation 39.05
|
1076.44 nmol/L
Standard Deviation 1387.85
|
26.09 nmol/L
Standard Deviation 49.42
|
791.08 nmol/L
Standard Deviation 868.18
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants.
Fecal myeloperoxidase will be measured at baseline and at 3 months.
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=21 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=21 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=22 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=22 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Fecal Myeloperoxidase
|
35.93 ng/ML
Standard Deviation 682.23
|
1071.01 ng/ML
Standard Deviation 2687.39
|
105.02 ng/ML
Standard Deviation 348.27
|
1225.78 ng/ML
Standard Deviation 1276.9
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants.
Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=21 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=21 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=22 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=22 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Alpha-1-Antitrypsin
|
3.28 mcg/L
Standard Deviation 25.57
|
-29.12 mcg/L
Standard Deviation 195.56
|
0.61 mcg/L
Standard Deviation 6.49
|
66.04 mcg/L
Standard Deviation 125.94
|
SECONDARY outcome
Timeframe: 1 and 3 monthsProportion of participants experiencing diarrhea (\> 3 watery stools in 24 hours).
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=23 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=23 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
n=22 Participants
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
n=23 Participants
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in the Prevalence of Diarrhea
|
-2 participants
|
1 participants
|
-1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: at enrollment and at 3 monthsPopulation: unable to review 24-hour pumped information from 1 mother in the placebo group
Breastmilk volume will be assessed from 24 hour breast pumping or hand expression or weighing the infant before and after feeding for 24 hours.
Outcome measures
| Measure |
Lactating Mothers (Moringa)
n=23 Participants
Lactating mothers.
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Breastfeeding Infants (Moringa)
n=21 Participants
Breastfeeding infants from lactating mothers
Moringa oleifera (high dose): Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
|
Lactating Mothers (Placebo)
Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo.
|
Breastfeeding Infants (Placebo)
Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo.
|
|---|---|---|---|---|
|
Change in Breastmilk Volume
|
435.9 mL
Standard Deviation 381.5
|
12.4 mL
Standard Deviation 465.7
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: outcome measure data not reported because unable to perform vitamin A analysis due to funding limitations
Levels of vitamin A in breastmilk will be measured at the end of the study.
Outcome measures
Outcome data not reported
Adverse Events
Lactating Mothers (Moringa)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breastfeeding Infants (Moringa)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lactating Mothers (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Breastfeeding Infants (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place