High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled Study

Nutrients. 2024 Feb 29;16(5):700. doi: 10.3390/nu16050700.

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.

Keywords: infant; interleukin-6; osteopenia; parathyroid hormone; premature; sepsis; vitamin D.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Bone Diseases, Metabolic* / epidemiology
  • Calcifediol
  • Dietary Supplements
  • Humans
  • Infant, Newborn
  • Infant, Premature
  • Interleukin-6
  • Randomized Controlled Trials as Topic
  • Vitamin D
  • Vitamin D Deficiency*
  • Vitamins

Substances

  • Calcifediol
  • Interleukin-6
  • Vitamin D
  • Vitamins

Grants and funding

This research received no external funding.