Growth Failure, Malnutrition, Wasting
Conditions
Keywords
Moringa oleifera, supplementation
Brief 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.
Interventions
DIETARY_SUPPLEMENTMoringa oleifera (high dose)
Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
DIETARY_SUPPLEMENTMoringa oleifera (low dose)
Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
DIETARY_SUPPLEMENTPlacebo
Mothers and children will receive porridge with placebo.
Sponsors
Fogarty International Center of the National Institute of Health
Suzanna L Attia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | at baseline and 3 months | Body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mid-Upper Arm Circumference | baseline and 3 months | Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months. Change from baseline to 3 months reported |
| Change in Vitamin A | 3 months | Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months.. |
| Change in CRP Levels | baseline and 3 months | 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. |
| Change in the Soluble Transferrin Receptor | baseline and 3 months | 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. |
| Change in Fecal Neopterin | baseline and 3 months | Fecal neopterin will be measured at baseline and at 3 months. |
| Change in Infant Height | at baseline and 3 months | Height (body length) |
| Change in Alpha-1-Antitrypsin | baseline and 3 months | Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months. |
| Change in the Prevalence of Diarrhea | 1 and 3 months | Proportion of participants experiencing diarrhea (\> 3 watery stools in 24 hours). |
| Change in Breastmilk Volume | at enrollment and at 3 months | Breastmilk volume will be assessed from 24 hour breast pumping or hand expression or weighing the infant before and after feeding for 24 hours. |
| Change in Breastmilk Vitamin A | baseline and 3 months | Levels of vitamin A in breastmilk will be measured at the end of the study. |
| Change in Fecal Myeloperoxidase | baseline and 3 months | Fecal myeloperoxidase will be measured at baseline and at 3 months. |
Countries
Kenya
Participant flow
Pre-assignment details
After trial registration, the children's groups were removed so no children were enrolled in the study
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Lactating Mothers (Placebo) Lactating mothers.
Placebo: Mothers and children will receive porridge with placebo. | 25 |
| Breastfeeding Infants (Placebo) Breastfeeding infants from lactating mothers
Placebo: Mothers and children will receive porridge with placebo. | 25 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Caregiver brought child to visits | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 0 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Lactating Mothers (Moringa) | Total | Breastfeeding Infants (Placebo) | Lactating Mothers (Placebo) | Breastfeeding Infants (Moringa) |
|---|---|---|---|---|---|
| Age, Continuous | 27.2 years STANDARD_DEVIATION 6 | 13.8 years STANDARD_DEVIATION 4.3 | .05 years STANDARD_DEVIATION 0.02 | 27.8 years STANDARD_DEVIATION 6.2 | 0.04 years STANDARD_DEVIATION 0.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 100 Participants | 25 Participants | 25 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 25 participants | 100 participants | 25 participants | 25 participants | 25 participants |
| Sex: Female, Male Female | 25 Participants | 72 Participants | 13 Participants | 25 Participants | 9 Participants |
| Sex: Female, Male Male | 0 Participants | 28 Participants | 12 Participants | 0 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Change in Body Weight
Body weight
Time frame: at baseline and 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Body Weight | 365 g | Standard Deviation 3102 |
| Breastfeeding Infants (Moringa) | Change in Body Weight | 2.5 g | Standard Deviation 0.9 |
| Lactating Mothers (Placebo) | Change in Body Weight | -470 g | Standard Deviation 2988 |
| Breastfeeding Infants (Placebo) | Change in Body Weight | 2.5 g | Standard Deviation 0.8 |
Secondary
Change in Alpha-1-Antitrypsin
Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.
Time frame: baseline and 3 months
Population: 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Alpha-1-Antitrypsin | 3.28 mcg/L | Standard Deviation 25.57 |
| Breastfeeding Infants (Moringa) | Change in Alpha-1-Antitrypsin | -29.12 mcg/L | Standard Deviation 195.56 |
| Lactating Mothers (Placebo) | Change in Alpha-1-Antitrypsin | 0.61 mcg/L | Standard Deviation 6.49 |
| Breastfeeding Infants (Placebo) | Change in Alpha-1-Antitrypsin | 66.04 mcg/L | Standard Deviation 125.94 |
Secondary
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
Population: outcome measure data not reported because unable to perform vitamin A analysis due to funding limitations
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.
Time frame: at enrollment and at 3 months
Population: unable to review 24-hour pumped information from 1 mother in the placebo group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Breastmilk Volume | 435.9 mL | Standard Deviation 381.5 |
| Breastfeeding Infants (Moringa) | Change in Breastmilk Volume | 12.4 mL | Standard Deviation 465.7 |
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.
Time frame: baseline and 3 months
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in CRP Levels | -3.5 mg/L | Standard Deviation 11.6 |
| Breastfeeding Infants (Moringa) | Change in CRP Levels | 2.3 mg/L | Standard Deviation 6.3 |
| Lactating Mothers (Placebo) | Change in CRP Levels | -5.3 mg/L | Standard Deviation 8.1 |
| Breastfeeding Infants (Placebo) | Change in CRP Levels | 8.8 mg/L | Standard Deviation 18.7 |
Secondary
Change in Fecal Myeloperoxidase
Fecal myeloperoxidase will be measured at baseline and at 3 months.
Time frame: baseline and 3 months
Population: 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Fecal Myeloperoxidase | 35.93 ng/ML | Standard Deviation 682.23 |
| Breastfeeding Infants (Moringa) | Change in Fecal Myeloperoxidase | 1071.01 ng/ML | Standard Deviation 2687.39 |
| Lactating Mothers (Placebo) | Change in Fecal Myeloperoxidase | 105.02 ng/ML | Standard Deviation 348.27 |
| Breastfeeding Infants (Placebo) | Change in Fecal Myeloperoxidase | 1225.78 ng/ML | Standard Deviation 1276.9 |
Secondary
Change in Fecal Neopterin
Fecal neopterin will be measured at baseline and at 3 months.
Time frame: baseline and 3 months
Population: 21 stool samples for the moringa group and 22 for the placebo group were successfully analyzed for mothers and infants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Fecal Neopterin | 21.56 nmol/L | Standard Deviation 39.05 |
| Breastfeeding Infants (Moringa) | Change in Fecal Neopterin | 1076.44 nmol/L | Standard Deviation 1387.85 |
| Lactating Mothers (Placebo) | Change in Fecal Neopterin | 26.09 nmol/L | Standard Deviation 49.42 |
| Breastfeeding Infants (Placebo) | Change in Fecal Neopterin | 791.08 nmol/L | Standard Deviation 868.18 |
Secondary
Change in Infant Height
Height (body length)
Time frame: at baseline and 3 months
Population: Height was not measured in the mothers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Infant Height | 9.1 cm | Standard Deviation 2.1 |
| Breastfeeding Infants (Moringa) | Change in Infant Height | 9.3 cm | Standard Deviation 1.7 |
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
Time frame: baseline and 3 months
Population: change in MUAC was not measured in the infants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Mid-Upper Arm Circumference | -1.7 cm | Standard Deviation 1.5 |
| Breastfeeding Infants (Moringa) | Change in Mid-Upper Arm Circumference | -1.6 cm | Standard Deviation 1.5 |
Secondary
Change in the Prevalence of Diarrhea
Proportion of participants experiencing diarrhea (\> 3 watery stools in 24 hours).
Time frame: 1 and 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lactating Mothers (Moringa) | Change in the Prevalence of Diarrhea | -2 participants |
| Breastfeeding Infants (Moringa) | Change in the Prevalence of Diarrhea | 1 participants |
| Lactating Mothers (Placebo) | Change in the Prevalence of Diarrhea | -1 participants |
| Breastfeeding Infants (Placebo) | Change in the Prevalence of Diarrhea | 3 participants |
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.
Time frame: baseline and 3 months
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in the Soluble Transferrin Receptor | -0.1 mg/L | Standard Deviation 2.8 |
| Breastfeeding Infants (Moringa) | Change in the Soluble Transferrin Receptor | 2.5 mg/L | Standard Deviation 2.1 |
| Lactating Mothers (Placebo) | Change in the Soluble Transferrin Receptor | -1.3 mg/L | Standard Deviation 2.6 |
| Breastfeeding Infants (Placebo) | Change in the Soluble Transferrin Receptor | 1.8 mg/L | Standard Deviation 2.7 |
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..
Time frame: 3 months
Population: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lactating Mothers (Moringa) | Change in Vitamin A | -0.29 mcmol/L | Standard Deviation 0.5 |
| Breastfeeding Infants (Moringa) | Change in Vitamin A | 0.08 mcmol/L | Standard Deviation 0.48 |
| Lactating Mothers (Placebo) | Change in Vitamin A | -0.23 mcmol/L | Standard Deviation 0.69 |
| Breastfeeding Infants (Placebo) | Change in Vitamin A | 0.09 mcmol/L | Standard Deviation 0.5 |