Vitamin D for Infants' Nutrition

Overseen By Renee Weatherly

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Antibiotics, Vitamin D supplements

Disqualifiers: Sarcoidosis, Renal disease, Premature birth, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the effect of Vitamin D on breastmilk and its benefits for infants. Researchers seek to understand how Vitamin D levels in breastmilk change after mothers take a Vitamin D supplement for 28 days and how this affects the nutrients infants receive. The trial consists of two parts: lactating mothers will take Vitamin D, and their infants will be monitored without intervention. Mothers who are breastfeeding two weeks after delivery and plan to continue can join, provided their infants are exclusively breastfed. This study excludes individuals with certain medical conditions, such as sarcoidosis or kidney disease. As an unphased trial, it offers a unique opportunity to contribute to understanding how Vitamin D supplementation can enhance infant nutrition through breastmilk.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are a lactating mother taking a daily supplement with 600 IU or more of vitamin D, you cannot participate. If your infant is currently on antibiotics or has taken them in the last two weeks, they cannot participate.

Is there any evidence suggesting that Vitamin D supplementation is safe for lactating women?

Research shows that Vitamin D supplements are generally safe for breastfeeding mothers. One study found that a daily dose of 6,400 IU of Vitamin D was well-tolerated by mothers and significantly increased Vitamin D levels in both mothers and their breast milk. This increase helps ensure babies receive enough Vitamin D through breast milk.

Another study found that a daily intake of 2,000 IU of Vitamin D improved mothers' Vitamin D levels and increased the Vitamin D content in their milk, supporting the baby's health.

Overall, these findings suggest that Vitamin D supplements are safe for breastfeeding mothers and effectively boost Vitamin D levels for both mother and baby. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Vitamin D3 for infants’ nutrition because it directly supports the mother's vitamin levels, which can enhance the nutritional content of breast milk. Unlike standard vitamin supplements that are typically given directly to infants, this approach focuses on boosting the mother's Vitamin D levels, potentially offering a more natural way to ensure infants receive adequate nutrition. Additionally, by administering Vitamin D3 to lactating women, it may offer a more efficient method to improve both maternal and infant health simultaneously.

What evidence suggests that Vitamin D supplementation is effective for improving breastmilk's nutritional value?

Research has shown that vitamin D supplements can significantly increase the vitamin D content in the breast milk of nursing mothers. In this trial, lactating women will receive Vitamin D3 for 28 days. One study found that when mothers took 6,400 IU of vitamin D3 daily, their breast milk's vitamin D levels matched those when both mothers and babies took supplements. Another study found that a higher weekly dose of 28,000 IU improved vitamin D levels in babies. These findings suggest that vitamin D supplements for breastfeeding mothers can effectively enhance the nutritional value of their milk, helping babies receive the vitamin D they need. ^{1 5 6 7 8}

Who Is on the Research Team?

Thomas Thatcher, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for breastfeeding mothers and their infants. Mothers must be currently lactating and willing to take Vitamin D supplements for 28 days. Infants involved should be receiving breastmilk. Participants with known conditions that affect vitamin D metabolism or allergies to Vitamin D supplements cannot join.

Inclusion Criteria

My infant is only fed breast milk.

Lactating mothers ≥2 weeks after delivery with no intentions of weaning during the study

Exclusion Criteria

I am a breastfeeding mother with a history of kidney problems.

My breastfeeding infant is on antibiotics or took them less than 2 weeks ago.

My breastfeeding infant has a diagnosed gastrointestinal disease needing treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Initial visit where demographic information is collected, and baseline samples are taken

1 day

1 visit (in-person)

Treatment

Lactating mothers receive Vitamin D3 supplementation for 28 days

4 weeks

1 visit (in-person)

Post-intervention

Follow-up visit to collect post-intervention samples and assess changes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin D

Trial Overview

The study measures the levels of Vitamin D sulfates in breastmilk and its nutritional value in an infant's saliva and gut after mothers take Vitamin D supplements for a month.

How Is the Trial Designed?

Group I: Lactating women Experimental Treatment 1 Intervention

Subjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days.

Group II: Breastfeeding Infants Active Control 1 Intervention

No intervention will be administered.

Vitamin D is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Approved in European Union as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Approved in Canada as Vitamin D for:

• Rickets
• Osteomalacia
• Osteoporosis
• Hypocalcemia
• Hyperparathyroidism
• Malabsorption states
• Cirrhosis
• Obesity

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

The EFSA Panel recommends a tolerable upper intake level (UL) of 100 μg/day for vitamin D in adults and adolescents, based on evidence of adverse effects like persistent hypercalciuria, which indicates excess vitamin D intake.

A conversion factor of 2.5 for calcidiol monohydrate to vitamin D3 is proposed for labeling, ensuring accurate representation of vitamin D content in supplements and foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate. Turck, D., Bohn, T., Castenmiller, J., et al.[2023]

In a study of 60 healthy neonates, a single oral dose of 2.5 mg of cholecalciferol every 3 months effectively maintained adequate vitamin D levels without causing toxicity, making it a safe option for high-risk infants.

Higher doses of 15 mg led to prolonged vitamin D overload in 50% of infants, indicating that lower doses are preferable to avoid potential side effects while still preventing vitamin D deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D prophylaxis during infancy: comparison of the long-term effects of three intermittent doses (15, 5, or 2.5 mg) on 25-hydroxyvitamin D concentrations. Zeghoud, F., Ben-Mekhbi, H., Djeghri, N., et al.[2018]

In a study of 495 healthy infants in south India, the prevalence of Vitamin D deficiency was found to be 22%, which is lower than previous reports in the region.

The study suggests that routine Vitamin D supplementation for pregnant women and infants may be necessary to address the public health issue of Vitamin D deficiency, despite no significant association found between breastfeeding duration and Vitamin D status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin-D deficiency and its association with breast feeding among children at 1 year of age in an urban community in South India. Gnanaraj, R., Lionel, BAP., Paranjape, M., et al.[2022]

In a study of 120 healthy infants aged 6-12 months in southern Thailand, 28.3% were found to have vitamin D insufficiency (VDI), particularly among those who were mainly breastfed.

The study identified that maternal vitamin D insufficiency and limited sunlight exposure were significant risk factors for VDI in infants, highlighting the importance of maternal health and adequate sunlight for preventing VDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and risk factors for vitamin D insufficiency in 6-12-month-old infants: a cross-sectional study in Southern Thailand. Kasemsripitak, S., Jaruratanasirikul, S., Boonrusmee, S., et al.[2022]

Cholecalciferol (vitamin D3) is the most effective and stable form of vitamin D for supplementation, while ergocalciferol (vitamin D2) is less potent and more prone to degradation during storage and cooking.

Current nutrition guidelines often overlook that calcidiol and calcitriol are not nutrients suitable for food fortification or dietary supplementation, emphasizing the need to focus on cholecalciferol for effective vitamin D intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D supplementation: cholecalciferol, calcifediol, and calcitriol. Vieth, R.[2021]

In a study of 57 patients with chronic kidney disease (CKD), cholecalciferol (D3) was found to significantly increase circulating vitamin D levels more than ergocalciferol (D2), with increases of 2.7 ng/ml for D3 compared to 1.1 ng/ml for D2 (p < 0.0001).

Younger females with lower baseline vitamin D levels showed a particularly strong response to cholecalciferol, suggesting that individual factors like age and sex may influence the effectiveness of vitamin D treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ergocalciferol versus Cholecalciferol for Nutritional Vitamin D Replacement in CKD. Mangoo-Karim, R., Da Silva Abreu, J., Yanev, GP., et al.[2015]

Vitamin D, including both D2 and D3, is crucial for regulating calcium and phosphate metabolism, which are essential for bone health and overall bodily functions.

The body produces vitamin D3 in the skin through sunlight exposure, and it is then converted into its active form, calcitriol, in the liver and kidneys, highlighting the importance of both sunlight and organ function in maintaining vitamin D levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Vitamin D metabolism]. Kulda, V.[2013]

The revised recommendation for vitamin D intake now suggests that all infants and children, including adolescents, should receive a minimum of 400 IU daily, starting soon after birth, to prevent rickets and other deficiencies.

This change is based on new clinical trial evidence and historical safety data, highlighting vitamin D's potential role in supporting immune function and possibly preventing diseases like diabetes and cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Wagner, CL., Greer, FR.[2022]

Cholecalciferol (vitamin D3) is nearly twice as effective as ergocalciferol (vitamin D2) in increasing serum levels of 25-hydroxyvitamin D (25(OH)D) in elderly women with vitamin D deficiency, based on a study of 32 participants.

The study found that oral administration of cholecalciferol led to significantly higher 25(OH)D levels compared to other forms, and that higher 25(OH)D levels were associated with lower parathyroid hormone (PTH) levels over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short and long-term variations in serum calciotropic hormones after a single very large dose of ergocalciferol (vitamin D2) or cholecalciferol (vitamin D3) in the elderly. Romagnoli, E., Mascia, ML., Cipriani, C., et al.[2022]

Vitamin D is essential for calcium absorption and bone health in infants, with a recommended daily intake of 400 IU for both preterm and full-term infants to prevent conditions like rickets, although rickets in premature infants is primarily due to calcium and phosphorus deficiency rather than vitamin D deficiency.

There is no strong evidence supporting routine testing of vitamin D levels or the need for high serum vitamin D levels in healthy infants, and while vitamin D toxicity is rare, care should be taken to avoid excessive doses from supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D in Preterm and Full-Term Infants. Abrams, SA.[2021]

Vitamin D3 (cholecalciferol) is more effective than Vitamin D2 (ergocalciferol) in raising serum levels of 25-hydroxyvitamin D, which is a key measure of vitamin D status in the body.

Due to its superior bioefficacy, Vitamin D2 should not be considered a suitable option for supplementation or fortification, as it has a shorter shelf life and less effective binding to vitamin D binding protein in plasma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The case against ergocalciferol (vitamin D2) as a vitamin supplement. Houghton, LA., Vieth, R.[2023]

In a study of 64 adults aged 65 and older, vitamin D3 (cholecalciferol) was found to be slightly more effective than vitamin D2 (ergocalciferol) in increasing serum 25-hydroxyvitamin D levels over one year, with 19% of participants still having low levels despite high compliance.

Neither vitamin D2 nor D3 caused toxicity or significant changes in serum calcium or other bone markers, but about 20% of individuals still had insufficient vitamin D levels after treatment, indicating variability in individual responses to supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of ergocalciferol or cholecalciferol dosing, 1,600 IU daily or 50,000 IU monthly in older adults. Binkley, N., Gemar, D., Engelke, J., et al.[2022]

A daily dose of 400 international units of vitamin D is effective in infants for improving bone health and preventing rickets, especially in at-risk groups.

Vitamin D supplementation is safe and well-tolerated, with no added benefits from higher doses, which could lead to toxicity; thus, universal supplementation is recommended from birth to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D prophylaxis in infancy. Jullien, S.[2021]

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Compare effectiveness of maternal vitamin D3 supplementation with 6400 IU per day alone to maternal and infant supplementation with 400 IU per day.

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Vitamin D - Drugs and Lactation Database (LactMed®) - NCBI

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Vitamin D Supplementation and Breastfeeding

The current recommendation for maternal vitamin D intake while breastfeeding is 400 to 600 IU per day, yet data suggest that supplementing the mother with this ...

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A dose of 6400 IU/day safely and significantly increased maternal vitD and 25(OH)D from baseline in all mothers regardless of feeding type (p < 0.0001) and was ...

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clinicaltrials.gov/study/NCT01240265

Vitamin D Supplementation in Breastfeeding Women

Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation.