A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial

Prem Fort1, Ariel A Salas1, Teodora Nicola1

  • 1Department of Pediatrics, University of Alabama at Birmingham, Birmingham, AL.

Insights

Extremely preterm infants often have vitamin D deficiency at birth. Supplementation with 200 IU/d improved vitamin D levels, while 800 IU/d prevented deficiency by day 28, though clinical outcomes did not differ.

Area of Science:

  • Neonatology
  • Pediatric Endocrinology
  • Nutritional Science

Background:

  • Extremely low gestational age newborns frequently present with biochemical vitamin D deficiency at birth.
  • Vitamin D sufficiency is crucial for infant health and development.
  • Optimal dosing strategies for vitamin D supplementation in this vulnerable population remain under investigation.

Purpose of the Study:

  • To ascertain the most effective dose of vitamin D supplementation required to achieve biochemical vitamin D sufficiency in extremely preterm infants.
  • To evaluate the impact of different vitamin D doses on serum 25-hydroxy vitamin D concentrations and clinical outcomes.

Main Methods:

  • A masked randomized controlled trial involving 100 infants born between 23 0/7 and 27 6/7 weeks gestation.
  • Infants were assigned to receive either placebo, 200 IU/d, or 800 IU/d of vitamin D, considering background nutritional support.
  • Primary outcomes included serum 25-hydroxy vitamin D levels on day 28 and days alive and off respiratory support.

Main Results:

  • At birth, 67% of infants exhibited vitamin D deficiency (serum 25-hydroxy vitamin D <20 ng/mL).
  • On day 28, median vitamin D levels were 22 ng/mL (placebo), 39 ng/mL (200 IU), and 84.5 ng/mL (800 IU) (P < .001).
  • No significant differences were observed in days alive and off respiratory support across the groups (P = .63).

Conclusions:

  • Vitamin D deficiency is prevalent at birth in extremely preterm infants.
  • Supplementation with 200 IU/d improves biochemical status, while 800 IU/d prevents deficiency by day 28.
  • Further research is needed to determine if correcting biochemical deficiency translates to improved clinical outcomes.
Abstract

Related Concept Videos

Drug Dosing: Infants and Children01:29

Drug Dosing: Infants and Children

Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
713
Dosage Regimen: Fixed Dose01:01

Dosage Regimen: Fixed Dose

Fixed-dose regimens are a common approach to administer drugs to achieve and maintain desired levels of the drug in the body. In this dosing strategy, a specific amount of medication is given at regular intervals, often multiple times a day, to ensure a consistent drug concentration in the bloodstream.
Fixed-dose regimens can be used for various routes of administration, including intravenous (IV) injections and oral medications. For IV administration, a predetermined amount of the drug is...
2.5K
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
453
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
279
Determination of Multiple Dosing Parameters: Loading and Maintenance Doses01:25

Determination of Multiple Dosing Parameters: Loading and Maintenance Doses

A loading dose is an essential pharmacological strategy to rapidly achieve the target plasma drug concentration necessary for an immediate therapeutic effect. This approach is especially critical for drugs characterized by slow absorption or extended half-lives, where delaying therapeutic plasma levels could compromise treatment outcomes. By administering a loading dose, clinicians ensure a prompt onset of drug action, even for agents with complex pharmacokinetic profiles.Achieving steady-state...
341
Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
254