Related Experiment Video
Updated: Jul 7, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a
Dominika Paw1, Renata Bokiniec1, Alicja Kołodziejczyk-Nowotarska1
1Department of Neonatology and Neonatal Intensive Care, Medical University of Warsaw, 00-315 Warsaw, Poland.
Insights
This study investigated monitored vitamin D supplementation for preterm infants. Higher initial doses may reduce neonatal sepsis and bone disease, improving infant health outcomes.
Area of Science:
- Neonatology
- Pediatric Endocrinology
- Nutritional Science
Background:
- Vitamin D deficiency is linked to bone disease and immune issues in preterm infants.
- Preterm infants (24-32 weeks gestation) are at high risk for these complications.
- Early assessment of vitamin D status is crucial for intervention.
Purpose of the Study:
- To evaluate the efficacy of monitored vitamin D supplementation in preterm infants.
- To determine if a high initial dose of vitamin D reduces neonatal sepsis and metabolic bone disease.
- To compare monitored supplementation with standard dosing protocols.
Main Methods:
- Randomized controlled trial involving preterm infants (24-32 weeks gestation).
- Measurement of 25-hydroxyvitamin D, parathyroid hormone, and interleukin-6 levels.
- Supplementation groups: monitored (1000 IU/day initially) vs. controlled (250-500 IU/day).
- Monitoring continued to 35 weeks postconceptional age.
Main Results:
- Primary endpoint: percentage of infants with deficient/suboptimal 25-hydroxyvitamin D at 28 days.
- Secondary endpoints: incidence of sepsis, osteopenia, hyperparathyroidism, and IL-6 levels.
- Analysis of vitamin D levels at 35 weeks postconceptional age.
Conclusions:
- Monitored vitamin D supplementation may be more effective in achieving optimal levels in preterm infants.
- High initial vitamin D doses warrant further investigation for preventing neonatal complications.
- Optimizing vitamin D status is critical for preterm infant development and health.
Abstract:
Vitamin D deficiency can escalate prematurity bone disease in preterm infants and negatively influence their immature immunology system. Infants born at 24 + 0/7 weeks to 32 + 6/7 weeks of gestation will be considered for inclusion. Cord or vein blood samples will be obtained within 48 h after birth for 25-hydroxyvitamin D level measurements. Parathyroid hormone and interleukin-6 levels will be measured. Infants will be randomized to the monitored group (i.e., an initial dose of 1000 IU/day and possible modification) or the controlled group (i.e., 250 IU/day or 500 IU/day dose, depending on weight). Supplementation will be monitored up to a postconceptional age of 35 weeks. The primary endpoint is the percentage of infants with deficient or suboptimal 25-hydroxyvitamin D levels at 28 ± 2 days of age. 25-Hydroxyvitamin D levels will be measured at postconceptional age 35 ± 2 weeks. Secondary goals encompass assessing the occurrence of sepsis, osteopenia, hyperparathyroidism, and interleukin-6 concentration. The aim of this study is to evaluate the efficacy of monitored vitamin D supplementation in a group of preterm infants and ascertain if a high initial dosage of monitored vitamin D supplementation can decrease the occurrence of neonatal sepsis and metabolic bone disease.
More Related Videos
Related Concept Videos
Dosage Regimen: Fixed Dose
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...
Bioavailability Study Design: Single Versus Multiple Dose Studies
Bioavailability Study Design: Healthy Subjects Versus Patients
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
Determination of Multiple Dosing Parameters: Loading and Maintenance Doses
Drug Dosing: Infants and Children

