Postnatal Multivitamins for Healthy Nutrition During Breastfeeding

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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Ritual Essential Postnatal Multivitamin for breastfeeding mothers?

Research indicates that vitamin and mineral supplements, like those found in postnatal multivitamins, do not significantly alter the vitamin levels in breast milk for well-nourished women. However, they may help ensure adequate intake of certain nutrients, such as vitamin B6, which some lactating women may not get enough of from diet alone. ^{1 2 3 4 5}

Is it safe to take postnatal multivitamins while breastfeeding?

Research indicates that vitamin supplementation, including multivitamins, does not significantly alter the nutritional status or breast milk composition in well-nourished women, suggesting it is generally safe during breastfeeding. ^{1 4 5 6 7}

How does the Ritual Epre Multimineral-Vitamin Supplement differ from other treatments for breastfeeding nutrition?

The Ritual Epre Multimineral-Vitamin Supplement is unique because it is specifically designed to support the nutritional needs of breastfeeding women, potentially enhancing the vitamin content of breast milk, which is crucial for the baby's development. Unlike some other treatments, it focuses on providing a comprehensive range of vitamins and minerals that may not be sufficiently obtained from diet alone, especially in women with low dietary intake of certain nutrients. ^{1 5 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Nutritional supplements and mother's milk composition: a systematic review of interventional studies. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Initial management of breastfeeding. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Acceptability of lipid-based nutrient supplements (LNS) among Ghanaian infants and pregnant or lactating women. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Vitamin B-6 intakes of lactating women: analyzed vs calculated values. [2015]

6. Switzerland 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. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Supplementation of breastfed infants: does continuing education for nurses make a difference? [2017]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of thiamin and riboflavin supplementation on the level of those vitamins in human breast milk and urine. [2018]

9. United States 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. [2018]

10. Russia (Federation) 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]. [2016]