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Nutritional Impact of Moringa Oleifera Leaf Supplementation in Mothers and Children
NA trial testing Moringa oleifera (high dose) in Malnutrition in 100 participants. Completed in 4 September 2022.
| Lead sponsor | Suzanna L Attia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 21 July 2021 |
| Primary completion | 4 September 2022 |
| Estimated completion | 4 September 2022 |
| Sites | 2 locations across Kenya |
Suzanna L Attia
Eligibility, any sex, with Malnutrition or Wasting. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Body weight
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | 365 | ± 3102 |
| Breastfeeding Infants (Moringa) | 2.5 | ± 0.9 |
| Lactating Mothers (Placebo) | -470 | ± 2988 |
| Breastfeeding Infants (Placebo) | 2.5 | ± 0.8 |
Height (body length)
| Group | Value | 95% CI |
|---|---|---|
| Breastfeeding Infants (Moringa) | 9.1 | ± 2.1 |
| Breastfeeding Infants (Placebo) | 9.3 | ± 1.7 |
Mid-upper arm circumference (MUAC) will be measured at baseline and monthly to 3 months. Change from baseline to 3 months reported
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | -1.7 | ± 1.5 |
| Lactating Mothers (Placebo) | -1.6 | ± 1.5 |
Serum retinol binding protein will be used to survey vitamin A levels in infants at baseline and monthly to 3 months..
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | -0.29 | ± 0.50 |
| Breastfeeding Infants (Moringa) | 0.08 | ± 0.48 |
| Lactating Mothers (Placebo) | -0.23 | ± 0.69 |
| Breastfeeding Infants (Placebo) | 0.09 | ± 0.50 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | -3.5 | ± 11.6 |
| Breastfeeding Infants (Moringa) | 2.3 | ± 6.3 |
| Lactating Mothers (Placebo) | -5.3 | ± 8.1 |
| Breastfeeding Infants (Placebo) | 8.8 | ± 18.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | -0.1 | ± 2.8 |
| Breastfeeding Infants (Moringa) | 2.5 | ± 2.1 |
| Lactating Mothers (Placebo) | -1.3 | ± 2.6 |
| Breastfeeding Infants (Placebo) | 1.8 | ± 2.7 |
Fecal neopterin will be measured at baseline and at 3 months.
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | 21.56 | ± 39.05 |
| Breastfeeding Infants (Moringa) | 1076.44 | ± 1387.85 |
| Lactating Mothers (Placebo) | 26.09 | ± 49.42 |
| Breastfeeding Infants (Placebo) | 791.08 | ± 868.18 |
Fecal myeloperoxidase will be measured at baseline and at 3 months.
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | 35.93 | ± 682.23 |
| Breastfeeding Infants (Moringa) | 1071.01 | ± 2687.39 |
| Lactating Mothers (Placebo) | 105.02 | ± 348.27 |
| Breastfeeding Infants (Placebo) | 1225.78 | ± 1276.9 |
Fecal alpha-1-antitrypsin will be measured at baseline and at 3 months.
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | 3.28 | ± 25.57 |
| Breastfeeding Infants (Moringa) | -29.12 | ± 195.56 |
| Lactating Mothers (Placebo) | 0.61 | ± 6.49 |
| Breastfeeding Infants (Placebo) | 66.04 | ± 125.94 |
Proportion of participants experiencing diarrhea (\> 3 watery stools in 24 hours).
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | -2 | |
| Breastfeeding Infants (Moringa) | 1 | |
| Lactating Mothers (Placebo) | -1 | |
| Breastfeeding Infants (Placebo) | 3 |
Breastmilk volume will be assessed from 24 hour breast pumping or hand expression or weighing the infant before and after feeding for 24 hours.
| Group | Value | 95% CI |
|---|---|---|
| Lactating Mothers (Moringa) | 435.9 | ± 381.5 |
| Lactating Mothers (Placebo) | 12.4 | ± 465.7 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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