Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Maimonides Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Multivitamin/multimineral supplements (MVI) provide important nutrition supplement to the diet of pregnant women to cover potential deficiencies and optimize nutrition status of both mom and baby, especially when the diet is suboptimal or nutrient demand is high while absorption is hindered by various factors such as genetic variance and gastrointestinal function. It is, however, largely unknown whether using an MVI during the lactating period helps improve nutrition status of mom and baby. In this double-blind, randomized, controlled trial, the investigators will recruit 7- postpartum women who exclusively breastfeed at week 5 postpartum and randomly assign them to either receive the Ritual MVI which is commercially available or a blank placebo for 10 weeks. A blank placebo is appropriate because there is currently no recommendation or scientific consensus that lactating women who are healthy and eat a normal diet would have improved nutrition status or maternal-infant health outcomes from a nutrition supplement. The investigators will collect blood and breastmilk samples at baseline and end of the study to assess nutrient status. The investigators hypothesize that consumption of a Ritual MVI leads to better nutrition status and biomarkers in maternal-child dyads compared to control.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ritual Epre | Experimental | This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily. |
|
| Control | Placebo Comparator | This group will receive a blank placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritual Epre Multimineral-Vitamin Supplement | Dietary Supplement | The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women. |
| Measure | Description | Time Frame |
|---|---|---|
| Breastmilk folate content | Breastmilk folate content will be measured | after 10 weeks of intervention |
| Breastmilk biotin content | Breastmilk biotin content will be measured. | after 10 weeks of intervention |
| Postpartum maternal blood folate status | Blood folate levels will be measured. | after 10 weeks of intervention |
| Postpartum maternal blood DHA status | Blood DHA levels will be measured. | after 10 weeks of intervention |
| Postpartum maternal blood vitamin B12 status | Blood B12 levels will be measured. | after 10 weeks of intervention |
| Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status | 3-HIA will be measured | after 10 weeks of intervention |
| Postpartum stress levels | The investigators will conduct the Edinburgh Postnatal Depression Scale (EPDS) assessment (maximum score 30, range 0-30, 10 or greater is considered possible depression). | at week 0 and after 10 weeks of intervention |
| human milk oligosaccharides (HMO) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooklyn College of City University of New York | Brooklyn | New York | 11210 | United States | ||
| Maimonides Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Women who exclusively breastfeed will be randomized at week 5 postpartum to either receive the Ritual MVI or a blank placebo for 10 weeks.
Not provided
Not provided
Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by Ritual and marked with randomly generated ID numbers. Grouping will be revealed by Ritual at end of the trial.
| Placebo Control | Dietary Supplement | This is a customarily designed blank placebo provided by Ritual. |
|
HMOs in breastmilk will be measured throughout the study.
| at week 0 and after 10 weeks of intervention |
| Potspartum maternal menaquinone-7 (vitamin K2) status | undercarboxylated Osteocalcin (ucOC), carboxylated osteocalcin (cOC) and MK-7 will be measured. | after 10 weeks of intervention |
| Breastmilk MK-7 content | Breastmilk MK-7 content will be measured. | after 10 weeks of intervention |
| Brooklyn |
| New York |
| 11219 |
| United States |