The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.

Vitamin D Deficiency Clinical Trial

— HIDVID  

Official title:

The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06199102
• Other study ID #: VitD-2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Contact: Dominika M Paw, MD
• Phone: 22 596 61 36
• Email: dominika.paw[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

Description:

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., 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 postconceptional age 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 objectives include the incidence of sepsis, osteopenia, hyperparathyroidism, and elevated interleukin-6 concentration. The aim of this study will be to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants and to determine whether a high initial dose of monitored vitamin D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 31, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 2 Days

Eligibility

Inclusion Criteria:

• preterm infants with a gestational age of 24+0/7 to 32+6/7 born at our clinic
• preterm infants with a gestational age of 24+0/7 to 32+6/7 outborn and admitted to our intensive care unit within 48h after delivery
• written informed consent form caregivers for the mother and the child to participate in the study

Exclusion Criteria:

• infants born at >32 weeks of gestation
• infants with major congenital abnormalities or other severe congenital malformations
• infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival
• infants with diagnosed cholestasis
• the absence of written informed consent and challenges in communication with caregivers

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Kidney Calculi
• Late-Onset Neonatal Sepsis
• Metabolic Bone Disease
• Neonatal Sepsis
• Nephrolithiasis
• Osteopenia of Prematurity
• Premature Birth
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• cholecalciferol/ Devikap
Infants in the monitored group will receive an initial dose of 1000 IU of vit D. An additional 160 IU/kg of vit D is included in parenteral nutrition, as well as 150-300 IU/kg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). At 28±2 days of age, blood samples will be obtained for 25(OH)D concentration measurement, followed by measurements every 4 weeks and/or 35±1 weeks of PCA. In the monitored group, vit D doses will be appropriately modified, based on 25(OH)D levels, using the scheme described in the Polish recommendation. The intake from the diet will be calculated from the second month of life.
• cholecalciferol/ Devikap
Infants in the controlled group will receive 250 IU for very low birth weight infants and 500 IU for infants weighing above 1000 g. An additional 160 IU/kg of vit D is included in parenteral nutrition, as well as 150-300 IU/kg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). Infants assigned to the standard therapy group will undergo the same blood sample collection procedure as the monitored group, but without any alterations in their dosing regimen.

Locations

Country	Name	City	State
Poland	Princess Anna Mazowiecka Hospital	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Princess Anna Mazowiecka Hospital, Warsaw, Poland	Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of infants with deficient or suboptimal 25(OH)D levels.	25-hydroxyvitamin D serum level below 30ng/ml	at 28±2 days of age, after that every 4 weeks (number of measurements depends on gestation age at birth) and/ or at 35±1 weeks of postconceptional age
Secondary	The number of infants with neonatal late-onset sepsis.	blood culture-proven (one blood sample of at least 1 mL) and/or clinical sepsis occurring after 3 days of age	after 3 days of age
Secondary	The number of infants with biochemical markers of metabolic bone disease.	serum levels of alkaline phosphatase >500 IU and serum phosphate <1.8 mmol/L	at 35±1 weeks of postconceptional age
Secondary	The number of infants with hyperparathyroidism.	serum or plasma concentration of PTH in infants should be 10-40 pg/mL	at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age
Secondary	The number of infants with high interleukin-6 levels.	the reference interval is calculated as 44 pg/mL; it is released within 2 h after the onset of bacteremia, peaks at approximately 6 h, and finally declines over the following 24 h	at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age
Secondary	The number of infants with nephrocalcinosis and nephrolithiasis.	venous samples for serum and urine calcium, and creatinine level measurements	at 28±2 days of life and at 35±1 weeks of postconceptional age
Secondary	The number of infants with potentially toxic 25(OH)D levels.	25-hydroxyvitamin D serum level exceeding 100 ng/mL	at 28±2 days of age, after that every 4 weeks (number of measurements depends on gestation age at birth) and/ or at 35±1 weeks of postconceptional age