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

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if giving very premature babies a high dose of vitamin D helps them more than a low dose. It focuses on extremely preterm infants who are fed human milk, aiming to support their bone growth and immune system.

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 vitamin D supplementation safe for preterm infants?

Vitamin D supplementation can be safe for preterm infants if monitored properly, as excessive amounts can lead to potentially toxic levels and health issues. In a study, monitored supplementation helped maintain safe vitamin D levels, while unmonitored supplementation led to toxic levels in some infants. ^{1 2 3 4 5}

How does vitamin D supplementation differ from other treatments for premature birth?

Vitamin D supplementation for premature birth is unique because it addresses the common issue of low vitamin D levels in preterm infants, which is not typically the focus of other treatments. Unlike other therapies, it specifically aims to improve vitamin D status, which is crucial for bone health and overall development in these infants. ^{3 5 6 7 8}

What data supports the effectiveness of the drug Vitamin D supplementation for premature birth?

Research suggests that vitamin D is important for growth and development, and preterm infants often have low levels of this nutrient. Supplementation may help prevent deficiencies that could lead to health issues, although the exact benefits and optimal doses are still being studied. ^{5 9 10 11 12}

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 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]

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]

Citations

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

Randomized trial of two doses of vitamin D3 in preterm infants [2018]

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

A randomized double-blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates. [2022]

3. India pubmed.ncbi.nlm.nih.gov

The a ssociation of 25-hydroxy Vitamin D level in mothers with term and preterm delivery and their neonates. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Determinants of vitamin D status in pregnant women and neonates. [2020]

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

Vitamin D, vitamin A, maternal-perinatal considerations: old concepts, new insights, new questions. [2013]

6. Australia pubmed.ncbi.nlm.nih.gov

Vitamin D and risk of preterm birth: Up-to-date meta-analysis of randomized controlled trials and observational studies. [2022]

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

Safety and Efficacy of Early Vitamin D Supplementation in Critically Ill Extremely Preterm Infants: An Ancillary Study of a Randomized Trial. [2023]

8. Ireland pubmed.ncbi.nlm.nih.gov

Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Monitored Supplementation of Vitamin D in Preterm Infants: A Randomized Controlled Trial. [2021]

10. Australia pubmed.ncbi.nlm.nih.gov

High prevalence of moderately severe vitamin D deficiency in preterm infants. [2018]

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

Serum 25 Hydroxy Vitamin D Levels in Very Low Birth Weight Infants Receiving Oral Vitamin D Supplementation. [2019]

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

Genetic predisposition for vitamin D deficiency is not associated with adverse outcome of very low birth weight infants: A cohort study from the German Neonatal Network. [2020]