An interventional study of cholecalciferol/ Devikap and cholecalciferol/ Devikap in Vitamin D Deficiency, Osteopenia of Prematurity and Nephrolithiasis, sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland. Not yet recruiting at 1 site in Poland. Open to participants aged 1 Day to 2 Days. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by Princess Anna Mazowiecka Hospital, Warsaw, Poland · Not applicable, Interventional, and Prevention
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.
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.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's planned enrollment of 130 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Princess Anna Mazowiecka Hospital, Warsaw, Poland is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infants in the monitored group will receive an initial dose of 1000 IU of vit D (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland).
Dietary Supplement: cholecalciferol/ Devikap
Infants in the controlled group will receive 250 IU (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland) for very low birth weight infants and 500 IU (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland) for infants weighing above 1000 g.
Dietary Supplement: cholecalciferol/ Devikap
Drug page: Cholecalciferol
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.
Drug page: Cholecalciferol
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.
The number of infants with deficient or suboptimal 25(OH)D levels.
25-hydroxyvitamin D serum level below 30ng/ml
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
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
Time frame: after 3 days of age
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
Time frame: at 35±1 weeks of postconceptional age
The number of infants with hyperparathyroidism.
serum or plasma concentration of PTH in infants should be 10-40 pg/mL
Time frame: at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age
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
Time frame: at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age
The number of infants with nephrocalcinosis and nephrolithiasis.
venous samples for serum and urine calcium, and creatinine level measurements
Time frame: at 28±2 days of life and at 35±1 weeks of postconceptional age
The number of infants with potentially toxic 25(OH)D levels.
25-hydroxyvitamin D serum level exceeding 100 ng/mL
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
Plan to share: Yes
Start is estimated for Sep 2024; primary completion for Sep 2027, 36 months later.
Of 168 non-industry interventional studies with no phase under Vitamin D Deficiency, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 29. This study's planned 36 months is above that.
Counting every sponsor, half of 170 studies reached it within 11 months; a quarter within 4 and three quarters within 29.
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This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol
Princess Anna Mazowiecka Hospital, Warsaw, Poland