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| Name | Class |
|---|---|
| Medical University of Warsaw | OTHER |
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The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.
Vitamin D (vit D) deficiency is a risk factor of osteopenia of prematurity, which leads to rickets or decreased bone mass mineral density. Recently multiple studies have been published on vit D adjust biological functions. Dosage, safety and effectiveness of vitD supplementation in preterm infants still remains a controversial topic. We hypothesize that monitored supplementation of vit D is more effective and safer than standard therapy 500IU in preterm infants. The study will be carried out in 138 preterm infants, born at 24-32 week of gestational age (GA) at the Princess Anne's Hospital in Warsaw, Poland. We will determine if monitored supplementation of vit D decreases the incidence of vit D deficiency and/or overdosing at 40 week (GA). For secondary objective we shall assess if monitored therapy reduces the incidence of vit D deficiency and/or overdosing at 35, 52 week (GA), prevalence of osteopenia, low bone mass, nephrocalcinosis and nephrolithiasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monitored group | Experimental | The monitored group will received monitored vit D supplementation |
|
| standard group | Active Comparator | The standard group will receive standard vit D supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monitored vit D supplementation | Dietary Supplement | The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born <30 GA, at 8 week of age for infants born <26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | at 40 (+/-2 weeks) PMA (postmenstrual age) |
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | at 4 weeks of age |
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | At 35 (+/-2 weeks) PMA (postmenstrual age) |
| Number of Participants with D- deficiency or access | 25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l ) | At 52 (+/-2 weeks) PMA (postmenstrual age) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with biochemical markers of osteopenia | ALP>500IU and serum phosphate level <1,8mmol/l or ALP>900IU | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) |
| average of bone mass |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with vitamin D- acceptable range | 25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 80ng/ml (200nmol/l ) | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) |
| Number of Participants with vitamin D- optimal range |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria K Borszewska-Kornacka, Professor | Princess Anna Mazowiecka Hospital | Study Chair |
| Renata Bokiniec, M.D. | Princess Anna Mazowiecka Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Anna Mazowiecka Hospital | Warsaw | 00-315 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10212074 | Background | Backstrom MC, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Kouri T, Maki M. Randomised controlled trial of vitamin D supplementation on bone density and biochemical indices in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1999 May;80(3):F161-6. doi: 10.1136/fn.80.3.f161. | |
| 17577338 | Background |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D001851 | Bone Diseases, Metabolic |
| D053040 | Nephrolithiasis |
| D062787 | Drug Overdose |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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|
| standard vit D supplementation | Dietary Supplement | The vitamin D supplementation dose is 500IU from 7th day of age. |
|
measurement of speed of sound [SOS] in meters per second in the axial transmission mode with a small ultrasound probe along the mid tibia by Sunlight Omnisence 7000 Premier using CRB Probe
| at 35, 40 (+/-2 weeks) PMA |
| Number of Participants with hypercalcemia | serum calcium level above 2,75mmol/l | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) |
| Number of Participants with hypercalcuria | urine calcium:creatinine ratio >3,8mmol/mmol for 0-4 week of age; >3,5mmol/mmol for 5-8 week of age; >2,8mmol/mmol for 9-12 week of age; >2,5mmol/mmol for 13-18 week of age; >2,2mmol/mmol for >19 week of age | at 35, 40, 52 (+/-2 weeks) PMA |
| Number of Participants with nephrocalcinosis | nephrocalcinosis detected in ultrasonography examination of kidneys | at 35, 52 (+/-2 weeks) PMA |
25-hydroxyvitamin D serum level between 30ng/ml (75nmol/l ) and 50ng/ml (125nmol/l )
| at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) |
| Avarage of vitamin D level | 25-hydroxyvitamin D serum level | at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age) |
| Rigo J, Pieltain C, Salle B, Senterre J. Enteral calcium, phosphate and vitamin D requirements and bone mineralization in preterm infants. Acta Paediatr. 2007 Jul;96(7):969-74. doi: 10.1111/j.1651-2227.2007.00336.x. |
| 25850574 | Background | Zerofsky M, Ryder M, Bhatia S, Stephensen CB, King J, Fung EB. Effects of early vitamin D deficiency rickets on bone and dental health, growth and immunity. Matern Child Nutr. 2016 Oct;12(4):898-907. doi: 10.1111/mcn.12187. Epub 2015 Apr 7. |
| 24189972 | Background | Zhu K, Whitehouse AJ, Hart PH, Kusel M, Mountain J, Lye S, Pennell C, Walsh JP. Maternal vitamin D status during pregnancy and bone mass in offspring at 20 years of age: a prospective cohort study. J Bone Miner Res. 2014;29(5):1088-95. doi: 10.1002/jbmr.2138. |
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| 24463662 | Background | Gernand AD, Simhan HN, Caritis S, Bodnar LM. Maternal vitamin D status and small-for-gestational-age offspring in women at high risk for preeclampsia. Obstet Gynecol. 2014 Jan;123(1):40-48. doi: 10.1097/AOG.0000000000000049. |
| 22331333 | Background | Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Kusel MM, Hart PH. Maternal serum vitamin D levels during pregnancy and offspring neurocognitive development. Pediatrics. 2012 Mar;129(3):485-93. doi: 10.1542/peds.2011-2644. Epub 2012 Feb 13. |
| 23542507 | Background | Pludowski P, Holick MF, Pilz S, Wagner CL, Hollis BW, Grant WB, Shoenfeld Y, Lerchbaum E, Llewellyn DJ, Kienreich K, Soni M. Vitamin D effects on musculoskeletal health, immunity, autoimmunity, cardiovascular disease, cancer, fertility, pregnancy, dementia and mortality-a review of recent evidence. Autoimmun Rev. 2013 Aug;12(10):976-89. doi: 10.1016/j.autrev.2013.02.004. Epub 2013 Mar 28. |
| 24456284 | Background | Vogiatzi MG, Jacobson-Dickman E, DeBoer MD; Drugs, and Therapeutics Committee of The Pediatric Endocrine Society. Vitamin D supplementation and risk of toxicity in pediatrics: a review of current literature. J Clin Endocrinol Metab. 2014 Apr;99(4):1132-41. doi: 10.1210/jc.2013-3655. Epub 2014 Jan 23. |
| 16399151 | Background | Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 Jan 7;367(9504):36-43. doi: 10.1016/S0140-6736(06)67922-1. |
| 21706518 | Background | Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. |
| 23070790 | Background | Whitehouse AJ, Holt BJ, Serralha M, Holt PG, Hart PH, Kusel MM. Maternal vitamin D levels and the autism phenotype among offspring. J Autism Dev Disord. 2013 Jul;43(7):1495-504. doi: 10.1007/s10803-012-1676-8. |
| 26226242 | Background | Cetinkaya M, Cekmez F, Erener-Ercan T, Buyukkale G, Demirhan A, Aydemir G, Aydin FN. Maternal/neonatal vitamin D deficiency: a risk factor for bronchopulmonary dysplasia in preterms? J Perinatol. 2015 Oct;35(10):813-7. doi: 10.1038/jp.2015.88. Epub 2015 Jul 30. |
| 25504199 | Background | Cizmeci MN, Kanburoglu MK, Akelma AZ, Ayyildiz A, Kutukoglu I, Malli DD, Tatli MM. Cord-blood 25-hydroxyvitamin D levels and risk of early-onset neonatal sepsis: a case-control study from a tertiary care center in Turkey. Eur J Pediatr. 2015 Jun;174(6):809-15. doi: 10.1007/s00431-014-2469-1. Epub 2014 Dec 12. |
| 23629620 | Background | 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. |
| 19881390 | Background | Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0. |
| 24002961 | Background | Pludowski P, Karczmarewicz E, Bayer M, Carter G, Chlebna-Sokol D, Czech-Kowalska J, Debski R, Decsi T, Dobrzanska A, Franek E, Gluszko P, Grant WB, Holick MF, Yankovskaya L, Konstantynowicz J, Ksiazyk JB, Ksiezopolska-Orlowska K, Lewinski A, Litwin M, Lohner S, Lorenc RS, Lukaszkiewicz J, Marcinowska-Suchowierska E, Milewicz A, Misiorowski W, Nowicki M, Povoroznyuk V, Rozentryt P, Rudenka E, Shoenfeld Y, Socha P, Solnica B, Szalecki M, Talalaj M, Varbiro S, Zmijewski MA. Practical guidelines for the supplementation of vitamin D and the treatment of deficits in Central Europe - recommended vitamin D intakes in the general population and groups at risk of vitamin D deficiency. Endokrynol Pol. 2013;64(4):319-27. doi: 10.5603/ep.2013.0012. |
| 23852093 | Background | Monangi N, Slaughter JL, Dawodu A, Smith C, Akinbi HT. Vitamin D status of early preterm infants and the effects of vitamin D intake during hospital stay. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F166-8. doi: 10.1136/archdischild-2013-303999. Epub 2013 Jul 13. |
| 25683497 | Background | Pinto K, Collins CT, Gibson RA, Andersen CC. Vitamin D in preterm infants: A prospective observational study. J Paediatr Child Health. 2015 Jul;51(7):679-81. doi: 10.1111/jpc.12847. Epub 2015 Feb 12. |
| 27079965 | Background | Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11. |
| 10943972 | Background | Backstrom MC, Kouri T, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Maki M. Bone isoenzyme of serum alkaline phosphatase and serum inorganic phosphate in metabolic bone disease of prematurity. Acta Paediatr. 2000 Jul;89(7):867-73. |
| 11795683 | Background | Nemet D, Dolfin T, Wolach B, Eliakim A. Quantitative ultrasound measurements of bone speed of sound in premature infants. Eur J Pediatr. 2001 Dec;160(12):736-40. doi: 10.1007/s004310100849. |
| 21681177 | Background | Rack B, Lochmuller EM, Janni W, Lipowsky G, Engelsberger I, Friese K, Kuster H. Ultrasound for the assessment of bone quality in preterm and term infants. J Perinatol. 2012 Mar;32(3):218-26. doi: 10.1038/jp.2011.82. Epub 2011 Jun 16. |
| 28893306 | Derived | Kolodziejczyk A, Borszewska-Kornacka MK, Seliga-Siwecka J. MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial. Trials. 2017 Sep 11;18(1):424. doi: 10.1186/s13063-017-2141-y. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |