180 Participants Needed

Vitamin D Supplementation for Premature Birth

Md
EK
Overseen ByEmily K Stephens, BSN, RNC-NIC
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether giving extremely premature infants a daily dose of vitamin D can improve their lung, bone, immune system, and brain health. The study focuses on babies born very early or with very low birth weight, who are at higher risk for health issues. Vitamin D supplementation has been studied extensively in preterm and low birth weight infants, showing improvements in growth and vitamin D status but mixed results on other health outcomes.

Will I have to stop taking my current medications?

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

Is vitamin D supplementation safe for premature infants?

Vitamin D supplementation in premature infants can be safe if monitored properly, as excessive amounts can lead to potentially toxic levels. In one study, 23% of infants on standard treatment had to stop due to high vitamin D levels, and two infants showed signs of vitamin D toxicity. Monitoring helps maintain safe levels and prevent overdose.12345

How does the drug 800 IU/day vitamin D supplementation differ from other treatments for premature birth?

The 800 IU/day vitamin D supplementation is unique because it provides a higher dose than the typical maximum of 400 IU/day used in other studies, aiming to improve vitamin D status and potentially enhance bone mineral density in preterm infants.678910

What data supports the effectiveness of the treatment 800 IU/day vitamin D supplementation for premature birth?

Research shows that early supplementation with 800 IU of vitamin D in very low birth weight infants is effective and safe, and it helps improve vitamin D levels in preterm infants, reducing the risk of vitamin D deficiency.1341112

Who Is on the Research Team?

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Maria del Mar Romero López, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

The ViDES Trial is for newborns born at less than 28 weeks gestational age or weighing under 1000 grams. It's not for babies with major birth defects, conditions like cystic fibrosis that affect vitamin D absorption, or those deemed too sick by their neonatologist. Babies over 32 weeks GA can't join regardless of weight.

Inclusion Criteria

Informed written consent in an Institutional Review Board (IRB)-approved manner
My baby was born before 28 weeks or weighed less than 1000 grams.
My condition is congenital.

Exclusion Criteria

My baby was born after 32 weeks of pregnancy.
Any major congenital anomaly
A known congenital nonbacterial infection
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Infants receive either placebo or vitamin D supplementation at 800 IU/day for the first 28 days after birth

4 weeks
Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including respiratory support and growth metrics

2 years

Long-term follow-up

Assessment of neurodevelopment and growth metrics at 2 years

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
  • Placebo
  • Usual Care
Trial Overview This trial tests if giving extremely premature infants an extra dose of vitamin D (800 IU/day) helps improve their bone health, lung function, immune system, and brain development compared to usual care during the first month after birth.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual care plus vitamin D supplementationExperimental Treatment2 Interventions
Group II: Usual care plus placeboActive Control2 Interventions

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Cholecalciferol for:
🇺🇸
Approved in United States as Vitamin D3 for:
🇨🇦
Approved in Canada as Cholecalciferol for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

The Gerber Foundation

Collaborator

Trials
45
Recruited
6,200+

Published Research Related to This Trial

In a study of 96 preterm infants, daily supplementation of 800 IU of vitamin D3 significantly reduced the prevalence of vitamin D deficiency compared to 400 IU, with rates of deficiency at 38.1% versus 66.7% at 40 weeks' postmenstrual age.
While the higher dose effectively lowered deficiency rates, it did not improve bone mineral content or density, and there was a small risk of vitamin D excess in one infant (2.4%).
Trial of daily vitamin D supplementation in preterm infants.Natarajan, CK., Sankar, MJ., Agarwal, R., et al.[2014]
In a study of 66 very low birth weight (VLBW) infants, early supplementation with 800 IU of vitamin D starting at 2 weeks of age was found to be safe and effective, achieving an 88% probability of vitamin D sufficiency by 36 weeks for those with initial levels ≥10 ng/mL.
For infants with lower initial vitamin D levels (<10 ng/mL), the supplementation still showed promise, with a 65% probability of achieving sufficiency, indicating that vitamin D intake may significantly improve vitamin D status in vulnerable populations like VLBW infants.
Efficacy and safety of early supplementation with 800 IU of vitamin D in very preterm infants followed by underlying levels of vitamin D at birth.Cho, SY., Park, HK., Lee, HJ.[2022]
In a study of 59 preterm infants born with a gestational age of less than 34 weeks, a single-dose intramuscular injection of 10,000 IU/kg of vitamin D3 significantly increased serum 25-hydroxyvitamin D levels by day 28 after birth compared to those receiving oral vitamin D3 drops.
The injection also resulted in a lower prevalence of vitamin D deficiency among the infants, with no reported cases of overdose or poisoning, indicating that this method is both safe and effective for improving vitamin D status in preterm infants.
[A comparative analysis of the efficacy of two vitamin D supplementation regimens in preterm infants: a prospective randomized controlled study].Ma, L., Geng, LM., Zhou, XH.[2020]

Citations

Trial of daily vitamin D supplementation in preterm infants. [2014]
Efficacy and safety of early supplementation with 800 IU of vitamin D in very preterm infants followed by underlying levels of vitamin D at birth. [2022]
[A comparative analysis of the efficacy of two vitamin D supplementation regimens in preterm infants: a prospective randomized controlled study]. [2020]
Vitamin D nutritional status of premature infants supplemented with 500 IU vitamin D2 per day. [2019]
A randomized double-blind controlled trial comparing two regimens of vitamin D supplementation in preterm neonates. [2022]
Vitamin D status and adequacy of standard supplementation in preterm neonates from South India. [2018]
Monitored Supplementation of Vitamin D in Preterm Infants: A Randomized Controlled Trial. [2021]
Randomised controlled trial of vitamin D supplementation on bone density and biochemical indices in preterm infants. [2019]
Serum 25 Hydroxy Vitamin D Levels in Very Low Birth Weight Infants Receiving Oral Vitamin D Supplementation. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Randomized trial of two doses of vitamin D3 in preterm infants [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Vitamin D Intake in Very Low Birth Weight Infants in Neonatal Intensive Care Unit. [2018]
Plasma 1.25-dihydroxyvitamin D concentrations in preterm infants. [2019]
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