Postnatal Multivitamins for Healthy Nutrition During Breastfeeding

Not currently recruiting at 1 trial location

Overseen By Xinyin Jiang, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City University of New York

Disqualifiers: Diabetes, Cardiovascular conditions, Liver disease

Compensation: Varies

Number of Visits: 2

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific multivitamin taken during breastfeeding improves nutrition for both mother and baby. Participants will take either a Ritual multivitamin or a placebo (a pill with no active ingredients) for 10 weeks. Researchers will analyze blood and breastmilk samples to assess the impact of the vitamins. Women who are exclusively breastfeeding and plan to continue for at least 10 more weeks may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to important nutritional research that could benefit breastfeeding mothers and their babies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study developed the Ritual Epre Multimineral-Vitamin Supplement to provide new mothers with essential nutrients during the first six months postpartum and while breastfeeding. This supplement includes 15 important nutrients for both mother and baby. Although specific safety data from trials is not mentioned in the sources, its availability in stores suggests general safety for most people, with few experiencing serious side effects. However, individual experiences may vary, so consulting a healthcare provider with any concerns is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other multivitamins available for breastfeeding mothers, the Ritual Epre supplement is unique because it combines both vitamins and minerals in a single, easy-to-take formula. This supplement aims to provide comprehensive nutritional support that aligns with the specific needs of postpartum women, potentially enhancing both maternal health and the quality of breast milk. Researchers are excited about Ritual Epre because it could offer a more convenient and targeted approach to postnatal nutrition, which might improve outcomes for both mothers and their babies compared to the standard multivitamin options.

What evidence suggests that the Ritual Epre multivitamin-mineral supplement could be effective for improving nutrition during breastfeeding?

Research has shown that taking multivitamins after giving birth can help meet the nutritional needs of new mothers. Some studies suggest these vitamins can fill gaps in a mother's diet, especially when breastfeeding increases nutrient demands. The Ritual Epre Multimineral-Vitamin Supplement provides 15 important nutrients for both mother and baby. However, whether these supplements actually improve nutrition during breastfeeding remains unclear. This trial aims to determine this by comparing the effects of the Ritual Epre supplement, given to participants in one arm, with a placebo, given to participants in another arm. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for postpartum women over 18 years old who are exclusively breastfeeding and plan to continue for at least 10 more weeks. It's not suitable for those with cardiovascular conditions, diabetes, or liver disease prior to or during pregnancy.

Inclusion Criteria

I am a woman over 10 years old and pregnant with one baby.

Women exclusively breast feeding and intending to exclusively breast feed for at least 10 more weeks

Exclusion Criteria

I have had heart conditions before and during my pregnancy.

I have had diabetes before and during my pregnancy.

I have had liver disease before and during my pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either the Ritual MVI or a placebo for 10 weeks

10 weeks

2 visits (in-person) at baseline and end of study

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Control
• Ritual Epre Multimineral-Vitamin Supplement

Trial Overview The study tests if taking Ritual Epre Multimineral-Vitamin Supplement improves nutrition in mothers and babies during lactation compared to a placebo. Participants will be randomly assigned to either the supplement group or placebo group in this double-blind trial.

How Is the Trial Designed?

Group I: Ritual Epre Experimental Treatment 1 Intervention

This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.

Group II: Control Placebo Group 1 Intervention

This group will receive a blank placebo.

Who Is Running the Clinical Trial?

City University of New York

Lead Sponsor

Trials

23

Recruited

6,000+

Maimonides Medical Center

Collaborator

Trials

72

Recruited

15,400+

Published Research Related to This Trial

Supplementation with a multivitamin-multimineral significantly increased the concentrations of vitamin B12 and folate in the breast milk of 16 low socioeconomic lactating women, indicating its efficacy in improving these vitamin levels.

Despite supplementation, there were no significant changes in ascorbic acid levels in breast milk, suggesting that additional dietary changes may be necessary to enhance overall vitamin content in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of ascorbic acid, vitamin B6, vitamin B12, and folic acid supplementation on the breast milk and maternal nutritional status of low socioeconomic lactating women. Sneed, SM., Zane, C., Thomas, MR.[2018]

A study of 58 newborns showed that mothers who took multivitamin supplements during pregnancy and breastfeeding had higher levels of vitamins C, B1, and B2 in their breast milk, which is crucial for the infants' nutritional needs.

Infants whose mothers did not take vitamin supplements had significantly lower urinary excretion of these vitamins, indicating a deficiency, and highlighting the importance of continued multivitamin intake during breastfeeding to ensure adequate vitamin supply for both mother and child.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of sufficiency with vitamins C, B1 and B2 of newborn infants feeding different types of nutrition, by means of urinary excretion determination]. Vrzhesinskaya, OA., Kodentsova, VM., Pereverzeva, OG., et al.[2016]

Lipid-based nutrient supplements (LNS) designed for infants and pregnant or lactating women were found to be highly acceptable, with infants consuming an average of 76.2% and women 87.1% of their test meals during the study.

The study involved 22 infants and 24 women in Ghana, and both groups maintained close to the recommended daily intake of the supplements over a 14-day period, indicating that LNS can effectively support micronutrient intake in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of lipid-based nutrient supplements (LNS) among Ghanaian infants and pregnant or lactating women. Adu-Afarwuah, S., Lartey, A., Zeilani, M., et al.[2022]

The study found that lactating women, two months postpartum and not taking vitamin B-6 supplements, had a mean intake of 1.45 mg of vitamin B-6, which is less than 70% of the recommended dietary allowance (RDA).

Despite the lower intake compared to the RDA, the dietary vitamin B-6 to protein ratio suggested that these women were consuming adequate amounts of vitamin B-6 for their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin B-6 intakes of lactating women: analyzed vs calculated values. Mangels, AR., Moser-Veillon, PB., Andon, MB., et al.[2015]

A continuing education program for nurses aimed at reducing formula supplementation in breastfed newborns did not lead to any change in supplementation practices after four weeks, with only 33% of newborns remaining unsupplemented during their hospital stay.

The study highlights that simply providing education is insufficient to change behavior; ongoing reinforcement and support are necessary to effectively implement and sustain changes in breastfeeding practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation of breastfed infants: does continuing education for nurses make a difference? Iker, CE., Mogan, J.[2017]

The workshop highlighted the need for public health strategies to improve supplementation of critical micronutrients like vitamin D, folic acid, and iron during pregnancy, lactation, and infancy, emphasizing their importance for maternal and infant health.

Participants called for more robust research, specifically well-designed human intervention trials, to determine the optimal amounts of these micronutrients for health benefits, which could inform future public health policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical micronutrients in pregnancy, lactation, and infancy: considerations on vitamin D, folic acid, and iron, and priorities for future research. Hermoso, M., Vollhardt, C., Bergmann, K., et al.[2013]

Maternal supplementation with certain vitamins, especially fat-soluble ones like vitamins A and D, as well as vitamins B1, B2, and C, can positively influence the composition of breast milk, as shown in a systematic review of various studies.

Higher doses of these vitamins tend to have a greater impact on breast milk content, particularly in colostrum compared to mature milk, indicating that the timing and amount of supplementation may be important for optimizing breast milk quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional supplements and mother's milk composition: a systematic review of interventional studies. Keikha, M., Shayan-Moghadam, R., Bahreynian, M., et al.[2021]

In a study of 12 women at 6 months postpartum, taking vitamin supplements did not significantly change the levels of key vitamins in breast milk compared to those who only followed a well-balanced diet.

Both groups had excellent dietary intakes, and the only notable difference was higher riboflavin intake in the supplemented group, indicating that vitamin supplementation may not be necessary for well-nourished women to maintain adequate breast milk vitamin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of vitamin C, vitamin B6, vitamin B12, folic acid, riboflavin, and thiamin on the breast milk and maternal status of well-nourished women at 6 months postpartum. Thomas, MR., Sneed, SM., Wei, C., et al.[2018]

Supplementation of thiamin and riboflavin during lactation did not show significant differences in breast milk concentrations between supplemented and nonsupplemented women, indicating that well-nourished women may not benefit from additional supplementation.

However, riboflavin levels in breast milk were significantly lower in nonsupplemented women, suggesting that while overall vitamin status was normal, supplementation may help maintain optimal riboflavin levels in lactating women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of thiamin and riboflavin supplementation on the level of those vitamins in human breast milk and urine. Nail, PA., Thomas, MR., Eakin, R.[2018]

Early initiation of breastfeeding, ideally within the first hour after birth, is crucial for successful breastfeeding and can be supported by skin-to-skin contact between mother and infant.

Postpartum practices such as rooming-in, providing guidance on breastfeeding challenges, and minimizing the use of formula and pacifiers can significantly improve breastfeeding rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial management of breastfeeding. Sinusas, K., Gagliardi, A.[2022]

Citations

1. ritual.com ritual.com/products/essential-postnatal-multivitamin?srsltid=AfmBOor_qT4-aHiazXQadAj41xNaGofVyhy8EJJ-5maw29bscAQiUp-C

Postnatal Vitamins | Essential Postnatal Essential Postnatal is formulated to help support a mother's new nutrient needs for 6 months postpartum and throughout lactation.*

2. amazon.com amazon.com/Ritual-Postpartum-Essentials-Multivitamin-Lactation/dp/B09W35QHJW

Ritual Essential for Women Postnatal Multivitamin ESSENTIAL FOR WOMEN POSTNATAL MULTIVITAMIN: is for the arrival of a mother's new nutrient needs. It's formulated with 15 key nutrients for 6 months ...

3. withpower.com withpower.com/trial/phase-lactation-disorders-2-2023-d81b5

Postnatal Multivitamins for Healthy Nutrition During Breastfeeding Trial Overview The study tests if taking Ritual Epre Multimineral-Vitamin Supplement improves nutrition in mothers and babies during lactation compared to a ...

4. ritual.com ritual.com/products/essential-postnatal-multivitamin-citrus?srsltid=AfmBOorIvam0QpjKnKzLx4NBgMyscTcWEg2l6LL74yn4QsG_ywBcbS_h

Postnatal Vitamins | Essential Postnatal Citrus Essential Postnatal is formulated to help support a mother's new nutrient needs for 6 months postpartum and throughout lactation.*

5. ctv.veeva.com ctv.veeva.com/study/use-of-ritual-epost-postnatal-multivitamins-during-the-postpartum-period

Use of Ritual Epost Postnatal Multivitamins During the ... It is, however, largely unknown whether using an MVI during the lactating period helps improve nutrition status of mom and baby. In this double- ...

6. ritual.com ritual.com/products/essential-postnatal-multivitamin?srsltid=AfmBOoongCOGD849zoxu-Se52gWcWfHHjo66Hs_xeoz-ilMiEFmGu8ce

Postnatal Vitamins | Essential Postnatal Essential Postnatal is formulated to help support a mother's new nutrient needs for 6 months postpartum and throughout lactation.*

7. ritual.com ritual.com/bundles/essential-skin-duo-postnatal?srsltid=AfmBOoq1RnzDXYt6JpkQQhRDCAueXz6Z7jqaA58HfWuVsE98ou5zuCgl

Essential Postnatal & Skin Duo The multivitamin for new nutrients up to 6 months postpartum, and throughout lactation, plus our daily skincare.

8. walmart.com walmart.com/ip/Ritual-Postpartum-Essentials-Multivitamin-Postnatal-Vitamin-Omega-3-DHA-Choline-Lactation-Support-Vitamin-A-C-D3-Zinc-Immune-Function-Support-B12-Iod/2421701288

Ritual Essential for Women Postnatal Multivitamin It's formulated with 15 key nutrients for 6 months postpartum, and throughout lactation. ... Safety Data Sheet · Terms of Use · Privacy Notice · California Supply ...