Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT06199102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2023-12-27', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of infants with deficient or suboptimal 25(OH)D levels.', 'timeFrame': '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', 'description': '25-hydroxyvitamin D serum level below 30ng/ml'}], 'secondaryOutcomes': [{'measure': 'The number of infants with neonatal late-onset sepsis.', 'timeFrame': 'after 3 days of age', 'description': 'blood culture-proven (one blood sample of at least 1 mL) and/or clinical sepsis occurring after 3 days of age'}, {'measure': 'The number of infants with biochemical markers of metabolic bone disease.', 'timeFrame': 'at 35±1 weeks of postconceptional age', 'description': 'serum levels of alkaline phosphatase \\>500 IU and serum phosphate \\<1.8 mmol/L'}, {'measure': 'The number of infants with hyperparathyroidism.', 'timeFrame': 'at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age', 'description': 'serum or plasma concentration of PTH in infants should be 10-40 pg/mL'}, {'measure': 'The number of infants with high interleukin-6 levels.', 'timeFrame': 'at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age', 'description': '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'}, {'measure': 'The number of infants with nephrocalcinosis and nephrolithiasis.', 'timeFrame': 'at 28±2 days of life and at 35±1 weeks of postconceptional age', 'description': 'venous samples for serum and urine calcium, and creatinine level measurements'}, {'measure': 'The number of infants with potentially toxic 25(OH)D levels.', 'timeFrame': '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', 'description': '25-hydroxyvitamin D serum level exceeding 100 ng/mL'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitamin D', 'preterm infants', 'osteopenia of prematurity', 'late-onset sepsis', 'metabolic bone disease'], 'conditions': ['Vitamin D Deficiency', 'Osteopenia of Prematurity', 'Nephrolithiasis', 'Metabolic Bone Disease', 'Late-Onset Neonatal Sepsis']}, 'referencesModule': {'references': [{'pmid': '21872800', 'type': 'BACKGROUND', 'citation': 'Lips P, van Schoor NM. The effect of vitamin D on bone and osteoporosis. Best Pract Res Clin Endocrinol Metab. 2011 Aug;25(4):585-91. doi: 10.1016/j.beem.2011.05.002.'}, {'pmid': '17634462', 'type': 'BACKGROUND', 'citation': 'Holick MF. Vitamin D deficiency. N Engl J Med. 2007 Jul 19;357(3):266-81. doi: 10.1056/NEJMra070553. No abstract available.'}, {'pmid': '25905252', 'type': 'BACKGROUND', 'citation': '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/'}, {'pmid': '27065162', 'type': 'BACKGROUND', 'citation': 'Khundmiri SJ, Murray RD, Lederer E. PTH and Vitamin D. Compr Physiol. 2016 Mar 15;6(2):561-601. doi: 10.1002/cphy.c140071.'}, {'pmid': '28383493', 'type': 'BACKGROUND', 'citation': 'Thorsen SU, Pipper CB, Skogstrand K, Pociot F, Svensson J. 25-Hydroxyvitamin D and Peripheral Immune Mediators: Results from Two Nationwide Danish Pediatric Cohorts. Nutrients. 2017 Apr 6;9(4):365. doi: 10.3390/nu9040365.'}, {'pmid': '36050673', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36771403', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19155428', 'type': 'BACKGROUND', 'citation': 'Taylor SN, Wagner CL, Hollis BW. Vitamin D supplementation during lactation to support infant and mother. J Am Coll Nutr. 2008 Dec;27(6):690-701. doi: 10.1080/07315724.2008.10719746.'}, {'pmid': '10690569', 'type': 'BACKGROUND', 'citation': 'Rigo J, De Curtis M, Pieltain C, Picaud JC, Salle BL, Senterre J. Bone mineral metabolism in the micropremie. Clin Perinatol. 2000 Mar;27(1):147-70. doi: 10.1016/s0095-5108(05)70011-7.'}, {'pmid': '23629620', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36705703', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34684442', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19190532', 'type': 'BACKGROUND', 'citation': 'Walker VP, Modlin RL. The vitamin D connection to pediatric infections and immune function. Pediatr Res. 2009 May;65(5 Pt 2):106R-113R. doi: 10.1203/PDR.0b013e31819dba91.'}, {'pmid': '25425653', 'type': 'BACKGROUND', 'citation': 'Dong Y, Speer CP. Late-onset neonatal sepsis: recent developments. Arch Dis Child Fetal Neonatal Ed. 2015 May;100(3):F257-63. doi: 10.1136/archdischild-2014-306213. Epub 2014 Nov 25.'}, {'pmid': '21527855', 'type': 'BACKGROUND', 'citation': 'Aranow C. Vitamin D and the immune system. J Investig Med. 2011 Aug;59(6):881-6. doi: 10.2310/JIM.0b013e31821b8755.'}, {'pmid': '33473300', 'type': 'BACKGROUND', 'citation': 'Workneh Bitew Z, Worku T, Alemu A. Effects of vitamin D on neonatal sepsis: A systematic review and meta-analysis. Food Sci Nutr. 2020 Nov 10;9(1):375-388. doi: 10.1002/fsn3.2003. eCollection 2021 Jan.'}, {'pmid': '15857558', 'type': 'BACKGROUND', 'citation': 'Haque KN. Definitions of bloodstream infection in the newborn. Pediatr Crit Care Med. 2005 May;6(3 Suppl):S45-9. doi: 10.1097/01.PCC.0000161946.73305.0A.'}, {'pmid': '21824193', 'type': 'BACKGROUND', 'citation': 'Bohnhorst B, Lange M, Bartels DB, Bejo L, Hoy L, Peter C. Procalcitonin and valuable clinical symptoms in the early detection of neonatal late-onset bacterial infection. Acta Paediatr. 2012 Jan;101(1):19-25. doi: 10.1111/j.1651-2227.2011.02438.x. Epub 2011 Aug 29.'}, {'pmid': '17369280', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29159088', 'type': 'BACKGROUND', 'citation': 'Rustico SE, Calabria AC, Garber SJ. Metabolic bone disease of prematurity. J Clin Transl Endocrinol. 2014 Jul 4;1(3):85-91. doi: 10.1016/j.jcte.2014.06.004. eCollection 2014 Sep.'}, {'pmid': '23056824', 'type': 'BACKGROUND', 'citation': 'Shahkar L, Keshtkar A, Mirfazeli A, Ahani A, Roshandel G. The role of IL-6 for predicting neonatal sepsis: a systematic review and meta-analysis. Iran J Pediatr. 2011 Dec;21(4):411-7.'}, {'pmid': '35402358', 'type': 'BACKGROUND', 'citation': 'Eichberger J, Resch B. Reliability of Interleukin-6 Alone and in Combination for Diagnosis of Early Onset Neonatal Sepsis: Systematic Review. Front Pediatr. 2022 Mar 23;10:840778. doi: 10.3389/fped.2022.840778. eCollection 2022.'}, {'pmid': '18780664', 'type': 'BACKGROUND', 'citation': 'Prinsen JH, Baranski E, Posch H, Tober K, Gerstmeyer A. Interleukin-6 as diagnostic marker for neonatal sepsis: determination of Access IL-6 cutoff for newborns. Clin Lab. 2008;54(5-6):179-83.'}, {'pmid': '16140692', 'type': 'BACKGROUND', 'citation': 'Barrueto F Jr, Wang-Flores HH, Howland MA, Hoffman RS, Nelson LS. Acute vitamin D intoxication in a child. Pediatrics. 2005 Sep;116(3):e453-6. doi: 10.1542/peds.2004-2580.'}, {'pmid': '34373793', 'type': 'BACKGROUND', 'citation': 'Al-Kandari A, Sadeq H, Alfattal R, AlRashid M, Alsaeid M. Vitamin D Intoxication and Nephrocalcinosis in a Young Breastfed Infant. Case Rep Endocrinol. 2021 Jul 30;2021:3286274. doi: 10.1155/2021/3286274. eCollection 2021.'}, {'pmid': '24253368', 'type': 'BACKGROUND', 'citation': 'Staub E, Wiedmer N, Staub LP, Nelle M, von Vigier RO. Monitoring of urinary calcium and phosphorus excretion in preterm infants: comparison of 2 methods. J Pediatr Gastroenterol Nutr. 2014 Apr;58(4):404-8. doi: 10.1097/MPG.0000000000000244.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants with a gestational age of 24+0/7 to 32+6/7 born at our clinic\n* 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\n* written informed consent form caregivers for the mother and the child to participate in the study\n\nExclusion Criteria:\n\n* infants born at \\>32 weeks of gestation\n* infants with major congenital abnormalities or other severe congenital malformations\n* infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival\n* infants with diagnosed cholestasis\n* the absence of written informed consent and challenges in communication with caregivers'}, 'identificationModule': {'nctId': 'NCT06199102', 'acronym': 'HIDVID', 'briefTitle': 'The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.', 'organization': {'class': 'OTHER', 'fullName': 'Princess Anna Mazowiecka Hospital, Warsaw, Poland'}, 'officialTitle': 'The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'VitD-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'monitored group', 'description': 'Infants in the monitored group will receive an initial dose of 1000 IU of vit D (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland).', 'interventionNames': ['Dietary Supplement: cholecalciferol/ Devikap']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'controlled group', 'description': '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.', 'interventionNames': ['Dietary Supplement: cholecalciferol/ Devikap']}], 'interventions': [{'name': 'cholecalciferol/ Devikap', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['monitored group']}, {'name': 'cholecalciferol/ Devikap', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['controlled group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-315', 'city': 'Warsaw', 'country': 'Poland', 'contacts': [{'name': 'Renata Bokiniec, PhD, MD', 'role': 'CONTACT', 'email': 'neonatologia@szpitalkarowa.pl', 'phone': '22 596 61 55', 'phoneExt': '+48'}], 'facility': 'Princess Anna Mazowiecka Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Dominika M Paw, MD', 'role': 'CONTACT', 'email': 'dominika.paw@wum.edu.pl', 'phone': '22 596 61 36', 'phoneExt': '+48'}, {'name': 'Alicja J Kołodziejczyk-Nowotarska, MD, PhD', 'role': 'CONTACT', 'email': 'alicja.kolodziejczyk-nowotarska@wum.edu.pl'}], 'overallOfficials': [{'name': 'Renata Bokiniec, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'renata.bokiniec@wum.edu.pl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Anna Mazowiecka Hospital, Warsaw, Poland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Warsaw', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Alicja Kołodziejczyk', 'investigatorAffiliation': 'Princess Anna Mazowiecka Hospital, Warsaw, Poland'}}}}