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NCT05736562 · ClinicalTrials.gov registry record · NA
Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period
A NA study of Nutrition, Healthy and Lactation Disorder - Postpartum Condition or Complication, sponsored by City University of New York.
- Active
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 2
- Study locations
NCT05736562: Active NA study of Nutrition, Healthy and Lactation Disorder - Postpartum Condition or Complication, sponsored by City University of New York.
NCT05736562 is a NA study of Nutrition, Healthy and Lactation Disorder - Postpartum Condition or Complication that is active but no longer recruiting, run by City University of New York. The registered enrollment target is 70 participants, below the 152-participant average among 31 other Nutrition, Healthy trials with a reported enrollment target (54% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05736562, a NA study of Nutrition, Healthy and Lactation Disorder - Postpartum Condition or Complication, is active but no longer recruiting, sponsored by City University of New York.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Breastmilk folate content will be measured
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Ritual Epre Multimineral-Vitamin Supplement
- DIETARY_SUPPLEMENT Placebo Control
Study Locations (2)
New York
- Brooklyn College of City University of New York - Brooklyn
- Maimonides Medical Center - Brooklyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-10-15 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT05736562 still lists
NCT05736562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 152-participant average among 31 other Nutrition, Healthy trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Nutrition, Healthy appearing as the primary indexed condition, and to 2 interventions - of which Ritual Epre Multimineral-Vitamin Supplement is the first listed.
NCT05736562 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05736562 about?
NCT05736562 is a clinical study titled "Use of Ritual Epost Postnatal Multivitamins During the Postpartum Period". 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 vario...
What is the current status of trial NCT05736562?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2023-10-15. Estimated completion is 2026-06-30.
What conditions does trial NCT05736562 study?
This clinical trial studies the following conditions: Nutrition, Healthy, Lactation Disorder - Postpartum Condition or Complication.
What interventions are being tested in trial NCT05736562?
The interventions under investigation include: Ritual Epre Multimineral-Vitamin Supplement (DIETARY_SUPPLEMENT), Placebo Control (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05736562?
This trial is sponsored by City University of New York, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05736562 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05736562's enrollment target sits among peer trials
70 22nd of 31 higher than 9 of 31 other Nutrition, Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nutrition, Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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