The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
NCT ID: NCT06199102
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2024-09-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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monitored group
Infants in the monitored group will receive an initial dose of 1000 IU of vit D (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland).
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.
controlled group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
1 Day
2 Days
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Princess Anna Mazowiecka Hospital, Warsaw, Poland
OTHER
Responsible Party
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Alicja Kołodziejczyk
MD, PhD
Principal Investigators
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Locations
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Princess Anna Mazowiecka Hospital
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.
Shaker JL, Deftos L. Calcium and Phosphate Homeostasis. 2023 May 17. In: Feingold KR, Ahmed SF, Anawalt B, Blackman MR, Boyce A, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hofland J, Kalra S, Kaltsas G, Kapoor N, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Singer F, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK279023/
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Pinto MRC, Machado MMT, de Azevedo DV, Correia LL, Leite AJM, Rocha HAL. Osteopenia of prematurity and associated nutritional factors: case-control study. BMC Pediatr. 2022 Sep 1;22(1):519. doi: 10.1186/s12887-022-03581-y.
Pludowski P, Kos-Kudla B, Walczak M, Fal A, Zozulinska-Ziolkiewicz D, Sieroszewski P, Peregud-Pogorzelski J, Lauterbach R, Targowski T, Lewinski A, Spaczynski R, Wielgos M, Pinkas J, Jackowska T, Helwich E, Mazur A, Ruchala M, Zygmunt A, Szalecki M, Bossowski A, Czech-Kowalska J, Wojcik M, Pyrzak B, Zmijewski MA, Abramowicz P, Konstantynowicz J, Marcinowska-Suchowierska E, Bleizgys A, Karras SN, Grant WB, Carlberg C, Pilz S, Holick MF, Misiorowski W. Guidelines for Preventing and Treating Vitamin D Deficiency: A 2023 Update in Poland. Nutrients. 2023 Jan 30;15(3):695. doi: 10.3390/nu15030695.
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Abrams SA; Committee on Nutrition. Calcium and vitamin d requirements of enterally fed preterm infants. Pediatrics. 2013 May;131(5):e1676-83. doi: 10.1542/peds.2013-0420. Epub 2013 Apr 29.
Embleton ND, Jennifer Moltu S, Lapillonne A, van den Akker CHP, Carnielli V, Fusch C, Gerasimidis K, van Goudoever JB, Haiden N, Iacobelli S, Johnson MJ, Meyer S, Mihatsch W, de Pipaon MS, Rigo J, Zachariassen G, Bronsky J, Indrio F, Koglmeier J, de Koning B, Norsa L, Verduci E, Domellof M. Enteral Nutrition in Preterm Infants (2022): A Position Paper From the ESPGHAN Committee on Nutrition and Invited Experts. J Pediatr Gastroenterol Nutr. 2023 Feb 1;76(2):248-268. doi: 10.1097/MPG.0000000000003642. Epub 2022 Oct 28.
Kolodziejczyk-Nowotarska A, Bokiniec R, Seliga-Siwecka J. Monitored Supplementation of Vitamin D in Preterm Infants: A Randomized Controlled Trial. Nutrients. 2021 Sep 28;13(10):3442. doi: 10.3390/nu13103442.
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Mercy J, Dillon B, Morris J, Emmerson AJ, Mughal MZ. Relationship of tibial speed of sound and lower limb length to nutrient intake in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2007 Sep;92(5):F381-5. doi: 10.1136/adc.2006.105742. Epub 2007 Mar 16.
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Other Identifiers
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VitD-2023
Identifier Type: -
Identifier Source: org_study_id
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