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NCT Number: NCT06199102

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Bone Diseases Bone Diseases, Metabolic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deficiency Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infections Inflammation Kidney Diseases Late-Onset Neonatal Sepsis Male Urogenital Diseases Malnutrition Metabolic Bone Disease Metabolic Diseases Musculoskeletal Diseases Neonatal Sepsis Nephrolithiasis Nutrition Disorders Nutritional and Metabolic Diseases Osteopenia of Prematurity Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases Urolithiasis Urologic Diseases

Age range

1 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this 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., 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cholecalciferol/ Devikap

Dietary Supplement

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.

Primary outcomes

  1. The number of infants with deficient or suboptimal 25(OH)D levels.

    Time frame: 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

    25-hydroxyvitamin D serum level below 30ng/ml

Secondary outcomes

  1. The number of infants with neonatal late-onset sepsis.

    Time frame: after 3 days of age

    blood culture-proven (one blood sample of at least 1 mL) and/or clinical sepsis occurring after 3 days of age

  2. The number of infants with biochemical markers of metabolic bone disease.

    Time frame: at 35±1 weeks of postconceptional age

    serum levels of alkaline phosphatase >500 IU and serum phosphate <1.8 mmol/L

  3. The number of infants with hyperparathyroidism.

    Time frame: at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age

    serum or plasma concentration of PTH in infants should be 10-40 pg/mL

  4. The number of infants with high interleukin-6 levels.

    Time frame: at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age

    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

  5. The number of infants with nephrocalcinosis and nephrolithiasis.

    Time frame: at 28±2 days of life and at 35±1 weeks of postconceptional age

    venous samples for serum and urine calcium, and creatinine level measurements

  6. The number of infants with potentially toxic 25(OH)D levels.

    Time frame: 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

    25-hydroxyvitamin D serum level exceeding 100 ng/mL

Study contacts

Contact information is provided by the study sponsor or research team.

Alicja J Kołodziejczyk-Nowotarska, MD, PhD

CONTACT

[email protected]

Dominika M Paw, MD

CONTACT

[email protected]

22 596 61 36 ext. +48

Sponsors and collaborators

Lead sponsor

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Other

Collaborators

  • Medical University of Warsaw

Registry information

Official study title

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

Acronym: HIDVID

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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