Lactation Disorder - Postpartum Condition or Complication, Nutrition, Healthy
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTRitual Epre Multimineral-Vitamin Supplement
The Ritual Epre supplement is a commercially available multivitamin-mineral supplement designed for pregnant and lactating women.
DIETARY_SUPPLEMENTPlacebo Control
This is a customarily designed blank placebo provided by Ritual.
Sponsors
City University of New York
Maimonides Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Women who exclusively breastfeed will be randomized at week 5 postpartum to either receive the Ritual MVI or a blank placebo for 10 weeks.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women are qualified to participate if they are over 10 years of age, having singleton pregnancy, and are exclusively breast feeding and intending to exclusively breast feed for at least 10 more weeks.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastmilk folate content | after 10 weeks of intervention | Breastmilk folate content will be measured |
| Breastmilk biotin content | after 10 weeks of intervention | Breastmilk biotin content will be measured. |
| Postpartum maternal blood folate status | after 10 weeks of intervention | Blood folate levels will be measured. |
| Postpartum maternal blood DHA status | after 10 weeks of intervention | Blood DHA levels will be measured. |
| Postpartum maternal blood vitamin B12 status | after 10 weeks of intervention | Blood B12 levels will be measured. |
| Postpartum maternal blood 3-hydroxyisovaleric acid (3-HIA) status | after 10 weeks of intervention | 3-HIA will be measured |
| Postpartum stress levels | at week 0 and after 10 weeks of intervention | The investigators will conduct the Edinburgh Postnatal Depression Scale (EPDS) assessment (maximum score 30, range 0-30, 10 or greater is considered possible depression). |
| human milk oligosaccharides (HMO) | at week 0 and after 10 weeks of intervention | HMOs in breastmilk will be measured throughout the study. |
| Potspartum maternal menaquinone-7 (vitamin K2) status | after 10 weeks of intervention | undercarboxylated Osteocalcin (ucOC), carboxylated osteocalcin (cOC) and MK-7 will be measured. |
| Breastmilk MK-7 content | after 10 weeks of intervention | Breastmilk MK-7 content will be measured. |
Countries
United States
Outcome results
None listed