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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-02-01
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| Series: | Nutrients |
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| Online Access: | https://www.mdpi.com/2072-6643/16/5/700 |
| _version_ | 1797264014927986688 |
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| author | Dominika Paw Renata Bokiniec Alicja Kołodziejczyk-Nowotarska |
| author_facet | Dominika Paw Renata Bokiniec Alicja Kołodziejczyk-Nowotarska |
| author_sort | Dominika Paw |
| collection | DOAJ |
| 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., 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. |
| first_indexed | 2024-04-25T00:22:10Z |
| format | Article |
| id | doaj.art-73c3f65f784740b7a727e48569ee4107 |
| institution | Directory Open Access Journal |
| issn | 2072-6643 |
| language | English |
| last_indexed | 2024-04-25T00:22:10Z |
| publishDate | 2024-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Nutrients |
| spelling | doaj.art-73c3f65f784740b7a727e48569ee41072024-03-12T16:52:15ZengMDPI AGNutrients2072-66432024-02-0116570010.3390/nu16050700High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled StudyDominika Paw0Renata Bokiniec1Alicja Kołodziejczyk-Nowotarska2Department of Neonatology and Neonatal Intensive Care, Medical University of Warsaw, 00-315 Warsaw, PolandDepartment of Neonatology and Neonatal Intensive Care, Medical University of Warsaw, 00-315 Warsaw, PolandDepartment of Neonatology and Neonatal Intensive Care, Medical University of Warsaw, 00-315 Warsaw, PolandVitamin 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.https://www.mdpi.com/2072-6643/16/5/700vitamin Dinfantprematureosteopeniasepsisinterleukin-6 |
| spellingShingle | Dominika Paw Renata Bokiniec Alicja Kołodziejczyk-Nowotarska High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled Study Nutrients vitamin D infant premature osteopenia sepsis interleukin-6 |
| title | High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled Study |
| title_full | High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled Study |
| title_fullStr | High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled Study |
| title_full_unstemmed | High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled Study |
| title_short | High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants (HIDVID Trial): Study Protocol for a Randomized Controlled Study |
| title_sort | high initial dose of monitored vitamin d supplementation in preterm infants hidvid trial study protocol for a randomized controlled study |
| topic | vitamin D infant premature osteopenia sepsis interleukin-6 |
| url | https://www.mdpi.com/2072-6643/16/5/700 |
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