Vitamin D Supplementation for Premature Birth

Overseen By Ariel A. Salas, MD, MSPH

Age: < 18

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Alabama at Birmingham

Disqualifiers: Congenital anomalies, Terminal illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different doses of vitamin D affect extremely premature babies fed human milk. Researchers aim to determine if higher doses of vitamin D improve growth and development compared to lower doses. The trial includes two groups: one receives a high dose of vitamin D, and the other a low dose. Babies born at 28 weeks or less, without major birth defects, are suitable candidates for this study. As a Phase 1, Phase 2 trial, the research focuses on understanding vitamin D's effects in these babies and measuring its effectiveness in promoting growth and development.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that vitamin D supplementation is likely to be safe for humans?

Research shows that vitamin D supplements are generally safe for premature babies. Studies have found that administering 800 IU of vitamin D daily can safely correct vitamin D deficiency by the time the baby reaches 14 days old. This supplementation is linked to positive short-term effects in these infants.

Previous research indicates that even higher doses, up to 4000 IU daily, are safe during pregnancy, suggesting that vitamin D is quite safe for both mothers and newborns. However, it's important to note that this trial is in an early stage. While vitamin D is mostly considered safe, ongoing studies are essential to confirm its safety in this specific setting. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using vitamin D supplementation for preventing premature births because it offers a natural, potentially safer alternative to current interventions, which often include medications like progesterone or lifestyle changes. Vitamin D is known for its role in bone health, but it also plays a part in immune function and inflammation reduction, which could be crucial in maintaining a healthy pregnancy. Unlike other treatments, which can have varying effects and side effects, vitamin D supplementation is simple and has a well-understood safety profile, making it a promising candidate for reducing the risk of premature delivery.

What evidence suggests that vitamin D supplementation might be an effective treatment for premature birth?

Research has shown that vitamin D can benefit preterm infants. One study found that a high dose of vitamin D (at least 800 IU per day) led to good short-term outcomes for these babies. Another study discovered that administering vitamin D through feeding improved growth and vitamin D levels in preterm and low birth weight infants. Although some studies have mixed results on vitamin D's effects during pregnancy, these findings suggest it can benefit babies born early. In this trial, participants in the Vitamin D group will receive vitamin D supplementation, while those in the Control group will receive a placebo. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for extremely preterm infants born at a gestational age of 28 weeks or less. Infants with terminal illnesses where life support is limited, or those with major congenital anomalies cannot participate.

Inclusion Criteria

Gestational age of 28 weeks or less

Exclusion Criteria

Terminal illness in whom decisions to withhold or limit life support have been made

My infant has a major birth defect.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Extremely preterm infants receive either the highest or lowest vitamin D dose recommended during the first 14 days after birth

2 weeks

Follow-up

Participants are monitored for respiratory outcomes and other health metrics

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin D supplementation

Trial Overview The study tests the effects of early vitamin D supplementation in very premature babies. They are randomly assigned to receive either high doses (intervention group) or low doses (control group) during their first two weeks after birth.

How Is the Trial Designed?

Group I: Vitamin D group Experimental Treatment 1 Intervention

Group II: Control group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a study of 109 preterm infants, monitored vitamin D supplementation (800-1000 IU) resulted in safer vitamin D levels compared to standard therapy, with a higher percentage of infants maintaining safe levels at 52 weeks of post-conceptional age.

Standard therapy led to a 23% discontinuation rate due to potentially toxic vitamin D levels, highlighting the importance of monitoring to prevent both deficiency and overdose in vitamin D supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitored Supplementation of Vitamin D in Preterm Infants: A Randomized Controlled Trial. Kołodziejczyk-Nowotarska, A., Bokiniec, R., Seliga-Siwecka, J.[2021]

In a study of 301 preterm infants, about 80% had deficient or insufficient vitamin D levels at 4 weeks of age, highlighting a common issue among very low birth weight (VLBW) and extremely low birth weight (ELBW) infants.

Vitamin D supplementation significantly improved 25-hydroxy vitamin D levels in VLBW infants by 8 and 12 weeks, while ELBW infants showed slower improvement, indicating that while supplementation is effective, monitoring is essential to prevent excessively high vitamin D levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum 25 Hydroxy Vitamin D Levels in Very Low Birth Weight Infants Receiving Oral Vitamin D Supplementation. Munshi, UK., Graziano, PD., Meunier, K., et al.[2019]

In a study of 32 preterm infants receiving either 400 or 800 IU/day of vitamin D3 for 4 weeks, those on the higher dose showed a significant increase in serum 25(OH)D3 levels, indicating better vitamin D status.

Infants receiving 400 IU/day were more likely to have low bone density, suggesting that an 800 IU/day dose may be more beneficial for improving bone health and overall growth in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of two doses of vitamin D3 in preterm infants Anderson-Berry, A., Thoene, M., Wagner, J., et al.[2018]

In a study of 120 preterm neonates, those receiving 1000 IU of vitamin D3 daily had a significantly lower prevalence of vitamin D insufficiency (2%) compared to those receiving 400 IU (64.6%) at 40 weeks of corrected gestational age.

While some infants on the higher dose experienced elevated vitamin D levels (9.8%), there were no signs of toxicity, suggesting that 1000 IU is a safe and effective supplementation level for reducing vitamin D insufficiency in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized double-blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates. Tergestina, M., Rebekah, G., Job, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8537871/

Monitored Supplementation of Vitamin D in Preterm Infants This study aimed to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants.

2. nature.com nature.com/articles/s41372-025-02440-9

Short-term and long-term effects of vitamin D ... High-dose (≥800 IU/day) vitamin D supplementation for preterm infants was associated with positive short-term outcomes, encompassing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S092966462300058X

Potential benefits of vitamin D supplementation on pregnancy We tested the hypothesis that increasing serum vitamin D levels of pregnant women to greater than 30 ng/mL is beneficial to pregnancy in this study.

4. publications.aap.org publications.aap.org/pediatrics/article/150/Supplement%201/e2022057092K/188647/Enteral-Vitamin-D-Supplementation-in-Preterm-or

Enteral Vitamin D Supplementation in Preterm or Low Birth ... Enteral vitamin D supplementation improves growth and vitamin D status in preterm and LBW infants.

5. academic.oup.com academic.oup.com/nutritionreviews/article/83/3/e892/7702409

The Effects of Vitamin D Supplementation During Pregnancy ... No effect of vitamin D on the risk of preterm birth, small-for-gestational age, or low birth weight infants was found.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35728797/

Safety and Efficacy of Early Vitamin D Supplementation in ... Conclusions: A vitamin D dose of 800 IU/day safely corrected vitamin D deficiency by Postnatal Day 14. Trial registration: ClinicalTrials.gov ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2475299123156447

Safety of Early Vitamin D Supplementation in Premature ... We defined safety outcomes based on 25 (OH) vitamin D concentrations at birth (D0), postnatal day 14 (D14), and postnatal day 28 (D28). Efficacy outcomes were ...

8. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-025-05765-8

Vitamin D-related risk factors for preterm and full-term infants ... The previous study [40] indicates that vitamin D supplementation of up to 4000 IU daily during pregnancy is safe. This would reduce the risk of ...