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

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.

Monitored Supplementation of Vitamin D in Preterm Infants: A Randomized Controlled Trial.

Appropriate supplementation of vitamin D can affect infections, allergy, and mental and behavioral development. This study aimed to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants. 109 preterm infants (24 0/7-32 6/7 weeks of gestation) were randomized to receive 500 IU vitamin D standard therapy (n = 55; approximately 800-1000 IU from combined sources) or monitored therapy (n = 54; with an option of dose modification). 25-hydroxyvitamin D [25(OH)D] concentrations were measured at birth, 4 weeks of age, and 35, 40, and 52 ± 2 weeks of post-conceptional age (PCA). Vitamin D supplementation was discontinued in 23% of infants subjected to standard treatment due to increased potentially toxic 25(OH)D concentrations (>90 ng/mL) at 40 weeks of PCA. A significantly higher infants' percentage in the monitored group had safe vitamin D levels (20-80 ng/mL) at 52 weeks of PCA (p = 0.017). We observed increased vitamin D levels and abnormal ultrasound findings in five infants. Biochemical markers of vitamin D toxicity were observed in two patients at 52 weeks of PCA in the control group. Inadequate and excessive amounts of vitamin D can lead to serious health problems. Supplementation with 800-1000 IU of vitamin D prevents deficiency and should be monitored to avoid overdose.