What side effects are associated with this type of intervention?

Common treatments for Vitamin D deficiency, such as Vitamin D2 (ergocalciferol) and Vitamin D3 (cholecalciferol) supplements, are generally well-tolerated but can have side effects. High doses of Vitamin D can lead to hypercalcemia, which may cause nausea, vomiting, weakness, and serious complications like kidney damage. Gastrointestinal upset is also a potential side effect. Additionally, high doses of Vitamin D may negatively impact pulmonary function and growth, particularly in children. Regular monitoring of serum Vitamin D levels is recommended to avoid these adverse effects.

What prior FDA approvals exist?

The FDA has approved several forms of vitamin D supplementation for the treatment of vitamin D deficiency, including vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol). These supplements are used to enhance 25(OH) vitamin D levels in the body, which is crucial for maintaining healthy bones, immune function, and overall health. High-dose vitamin D3 supplementation has been studied for its potential benefits in various conditions, including bone health and immune function, similar to the aims of the ViDES trial. These treatments are available in various forms, such as oral tablets, capsules, and liquid formulations, to cater to different patient needs.

What other types of research exist?

Currently, there are no specific novel alternatives to Vitamin D supplementation mentioned in the provided context. Patients should consider maintaining a balanced diet rich in Vitamin D, engaging in regular sunlight exposure, and discussing with their healthcare provider about any emerging therapies or nutritional interventions that may support overall health and address Vitamin D deficiency.

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Vitamin D Supplement

Vitamin D Supplementation for Premature Birth

N/A

Recruiting

Led By Maria del Mar Romero López, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves supplementation in very young infants, side effects are monitored closely but may include typical reactions to supplements such as digestive discomfort or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

Neurodevelopmental Disorders

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Usual care plus vitamin D supplementationExperimental Treatment2 Interventions

Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day (when feedings reach about 120 -160 mL/kg/day). At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.

Group II: Usual care plus placeboActive Control2 Interventions

Infants will receive placebo (normal saline) in the first 28 days after birth. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Vitamin D supplementation, typically in the form of cholecalciferol (D3) or ergocalciferol (D2), works by increasing the levels of 25-hydroxyvitamin D [25(OH)D] in the blood. This is crucial for patients with Vitamin D deficiency as it helps in calcium absorption, promoting bone health and reducing the risk of fractures. Additionally, adequate Vitamin D levels support immune function, potentially reducing the risk of infections and inflammation. Emerging evidence also suggests benefits for muscle strength, lung function, and possibly cognitive health. Ensuring sufficient Vitamin D levels is therefore essential for overall health and the prevention of various deficiency-related complications.

Musculoskeletal Pain and Vitamin D Deficiency in Children: A Pilot Follow-up Study of Vitamin D Therapy in Musculoskeletal/Orthopedic Conditions.Vitamin D Supplementation for Childhood Asthma: A Systematic Review and Meta-Analysis.Vitamin D supplementation during rehabilitation in COPD: a secondary analysis of a randomized trial.