Association Between Vitamin D Receptor Polymorphism and Serum Vitamin D Levels in Children With Low-Energy Fractures
NCT ID: NCT02805647
Last Updated: 2019-12-04
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
222 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-01-31
Study Completion Date
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study was designed to determine the impact of vitamin D serum levels and vitamin D receptor (VDR) polymorphisms on the occurrence of low energy fractures in children.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Vitamin K2 and D3 Intervention Trial in Children and Adolescents With the Low-energy Fractures
NCT03871322
Fracture Healing
Vitamin D3
Deficiency of Vitamin K2
UNKNOWN
NA
Vitamin D Supplement for Patients With Tibial Fracture
NCT01955577
Tibial Fracture
UNKNOWN
PHASE1
Relationships Between Vitamin D and Orthopedic Trauma
NCT04564625
Fracture
Fracture Nonunion
Fractures, Bone
+1 more
UNKNOWN
Vitamin D Administration in the Nursing Home
NCT00204919
Vitamin D Deficiency
Osteoporosis
COMPLETED
NA
Optimal Vitamin D3 Supplementation Strategies for Acute Fracture Healing
NCT02786498
Fracture
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures. The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures. Children with osteogenesis imperfecta (OI) were excluded from the study. From each patient and their parent/guardian a written informed consent to participate in the study was obtained. Low-energy fracture was defined as a fracture sustained from a fall from the patient's own height or a fall during team games. All fractures were radiologically confirmed.
During hospitalization the patients and their parents completed a questionnaire on demographic data, the place of residence (urban/rural), earlier fractures and physical activity. The degree of sexual maturity was assessed using a survey of puberty development on the basis of Puberty Development Scale \[20-22\]. The patients' body weights and heights were measured, and the Cole indicator was calculated to assess the nutritional status of the patients.
Serum concentrations of total vitamin D \[25-hydroxy vitamin D3 ((25(OH)D3)) plus 25-hydroxy vitamin D2 ((25(OH)D2))\] in the plasma of all the children were determined by electrochemiluminescence using paramagnetic particles coated with streptavidin and ruthenium compound on the Cobas e 411 apparatus by Roche. According to our laboratory, the reference value range for total vitamin D was 30.0 - 74.0 ng/ml.Whole blood samples were collected in tubes containing EDTA and stored at -20°C. DNA was isolated using the MasterPureTM DNA Purification Kit (Akor Laboratories) and quantified on a spectrophotometer (Nanodrop 2000, Thermo Scientific). The genotypes for four restriction fragment length polymorphisms of the vitamin D receptor (VDR) gene were determined by standard polymerase chain reaction (PCR) techniques and enzymatic digestion of the products with FokI, ApaI, TaqI and BsmI (Thermo Scientific). In short, PCR were performed in a final volume of 20 µl containing 50-100 ng DNA, 0.3 µM of each primer and JumpStartTM REDTaqTM ReadyMixTM (Sigma). After initial denaturation for 3 min at 94 °C, samples were subjected to 35 cycles of amplification, consisting of a 30-sec denaturing phase at 94 °C, a 30-sec annealing phase (FokI at 60 °C, ApaI and TaqI at 70 °C, BsmI at 62 °C), a 30-s extension phase at 72 °C, and 4-min at 72 °C on a Bio-Rad thermal cycler CFX96TM. The primers used for FokI polymorphism were: forward 5'-AGC TGG CCC TGG CAC TGA CTC TGC TCT-3', reverse 5'-ATG GAA ACA CCT TGC TTC TTC TCC CTC-3'; ApaI and TaqI: forward 5'-CAG AGC ATG GAC AGG GAG CAA-3', reverse 5'-GCA ACT CCT CAT GGC TGA GGT CTC-3' and BsmI: forward 5'-AGT GTG CAG GCG ATT CGT AG-3', reverse 5'-ATA GGC AGA ACC ATC TCT CAG-3' \[25\]. The PCR products were digested according to the manufacturer's instructions and separated on 2% agarose gel. The polymorphisms were documented by photographing under UV illumination using G:Box (Syngene). A random subset (20% of samples) was repeated to verify the results. Upper case letters "F", "A", "T" and "B" indicate the absence of the cut site for FokI, ApaI, TaqI and BsmI polymorphisms, respectively, whereas lower case letters "f", "a", "t", and "b" indicate its presence.To examine the relationships between quality attributes Chi-square test of independence and Fisher's exact test were used. The normality of distribution was verified using the Kolmogorov-Smirnov test with the Lilliefors significance correction and the Shapiro-Wilk test. There was no normal distribution of quantitative variables analyzed. To compare the quantitative variables without normal distribution a nonparametric Mann - Whitney U test was used. Models of uni-variate and multi-variate linear regression and logistic regression were established. Results were considered statistically significant at p \<0.05. The calculations were performed using Statistica 10.0 by StatSoft, IBM SPSS Statistics 21.0 by Predictive Solutions Company and Stata / IC 13.1 packages by StataCorp LP
During hospitalization the patients and their parents completed a questionnaire on demographic data, the place of residence (urban/rural), earlier fractures and physical activity. The degree of sexual maturity was assessed using a survey of puberty development on the basis of Puberty Development Scale \[20-22\]. The patients' body weights and heights were measured, and the Cole indicator was calculated to assess the nutritional status of the patients.
Serum concentrations of total vitamin D \[25-hydroxy vitamin D3 ((25(OH)D3)) plus 25-hydroxy vitamin D2 ((25(OH)D2))\] in the plasma of all the children were determined by electrochemiluminescence using paramagnetic particles coated with streptavidin and ruthenium compound on the Cobas e 411 apparatus by Roche. According to our laboratory, the reference value range for total vitamin D was 30.0 - 74.0 ng/ml.Whole blood samples were collected in tubes containing EDTA and stored at -20°C. DNA was isolated using the MasterPureTM DNA Purification Kit (Akor Laboratories) and quantified on a spectrophotometer (Nanodrop 2000, Thermo Scientific). The genotypes for four restriction fragment length polymorphisms of the vitamin D receptor (VDR) gene were determined by standard polymerase chain reaction (PCR) techniques and enzymatic digestion of the products with FokI, ApaI, TaqI and BsmI (Thermo Scientific). In short, PCR were performed in a final volume of 20 µl containing 50-100 ng DNA, 0.3 µM of each primer and JumpStartTM REDTaqTM ReadyMixTM (Sigma). After initial denaturation for 3 min at 94 °C, samples were subjected to 35 cycles of amplification, consisting of a 30-sec denaturing phase at 94 °C, a 30-sec annealing phase (FokI at 60 °C, ApaI and TaqI at 70 °C, BsmI at 62 °C), a 30-s extension phase at 72 °C, and 4-min at 72 °C on a Bio-Rad thermal cycler CFX96TM. The primers used for FokI polymorphism were: forward 5'-AGC TGG CCC TGG CAC TGA CTC TGC TCT-3', reverse 5'-ATG GAA ACA CCT TGC TTC TTC TCC CTC-3'; ApaI and TaqI: forward 5'-CAG AGC ATG GAC AGG GAG CAA-3', reverse 5'-GCA ACT CCT CAT GGC TGA GGT CTC-3' and BsmI: forward 5'-AGT GTG CAG GCG ATT CGT AG-3', reverse 5'-ATA GGC AGA ACC ATC TCT CAG-3' \[25\]. The PCR products were digested according to the manufacturer's instructions and separated on 2% agarose gel. The polymorphisms were documented by photographing under UV illumination using G:Box (Syngene). A random subset (20% of samples) was repeated to verify the results. Upper case letters "F", "A", "T" and "B" indicate the absence of the cut site for FokI, ApaI, TaqI and BsmI polymorphisms, respectively, whereas lower case letters "f", "a", "t", and "b" indicate its presence.To examine the relationships between quality attributes Chi-square test of independence and Fisher's exact test were used. The normality of distribution was verified using the Kolmogorov-Smirnov test with the Lilliefors significance correction and the Shapiro-Wilk test. There was no normal distribution of quantitative variables analyzed. To compare the quantitative variables without normal distribution a nonparametric Mann - Whitney U test was used. Models of uni-variate and multi-variate linear regression and logistic regression were established. Results were considered statistically significant at p \<0.05. The calculations were performed using Statistica 10.0 by StatSoft, IBM SPSS Statistics 21.0 by Predictive Solutions Company and Stata / IC 13.1 packages by StataCorp LP
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Vitamin D Receptor Defect
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fracture/study group
The study group consisted of 100 children aged 3 to 18 years (78% boys) hospitalized in the Department of Pediatric Orthopedics in 2011-2013 due to low-energy fractures
No interventions assigned to this group
Control group
The control group (122 children, 68% boys) consisted of children aged 3 to 17 years, hospitalized for other reasons (injuries, diagnosis of knee ligament injuries and others) without fractures
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* low-energy fractures.
* healthy children hospitalized for other reasons than fractures (injuries, diagnosis of knee ligament injuries and others) without fractures
* healthy children hospitalized for other reasons than fractures (injuries, diagnosis of knee ligament injuries and others) without fractures
Exclusion Criteria
* Children with osteogenesis imperfecta (OI) were excluded from the study.
Minimum Eligible Age
1 Year
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
American Medical Holdings Inc., Staten Island, NY 10314 USA
UNKNOWN
Sponsor Role
collaborator
School of Pharmacy, Creighton University, Omaha, NE 68178 USA
UNKNOWN
Sponsor Role
collaborator
Medical University of Bialystok
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michal Karpinski
MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michał Karpiński, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Bialystok, , Poland
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Poland
References
Explore related publications, articles, or registry entries linked to this study.
Jones IE, Williams SM, Dow N, Goulding A. How many children remain fracture-free during growth? a longitudinal study of children and adolescents participating in the Dunedin Multidisciplinary Health and Development Study. Osteoporos Int. 2002 Dec;13(12):990-5. doi: 10.1007/s001980200137.
Reference Type
BACKGROUND
Ma D, Jones G. Soft drink and milk consumption, physical activity, bone mass, and upper limb fractures in children: a population-based case-control study. Calcif Tissue Int. 2004 Oct;75(4):286-91. doi: 10.1007/s00223-004-0274-y. Epub 2004 Jul 30.
Reference Type
BACKGROUND
Wyshak G, Frisch RE. Carbonated beverages, dietary calcium, the dietary calcium/phosphorus ratio, and bone fractures in girls and boys. J Adolesc Health. 1994 May;15(3):210-5. doi: 10.1016/1054-139x(94)90506-1.
Reference Type
BACKGROUND
Carey DE, Golden NH. Bone Health in Adolescence. Adolesc Med State Art Rev. 2015 Aug;26(2):291-325.
Reference Type
BACKGROUND
Manning Ryan L, Teach SJ, Searcy K, Singer SA, Wood R, Wright JL, Hunting KL, Chamberlain JM. The Association Between Weight Status and Pediatric Forearm Fractures Resulting From Ground-Level Falls. Pediatr Emerg Care. 2015 Dec;31(12):835-8. doi: 10.1097/PEC.0000000000000628.
Reference Type
BACKGROUND
Yao Y, Zhu L, He L, Duan Y, Liang W, Nie Z, Jin Y, Wu X, Fang Y. A meta-analysis of the relationship between vitamin D deficiency and obesity. Int J Clin Exp Med. 2015 Sep 15;8(9):14977-84. eCollection 2015.
Reference Type
BACKGROUND
Thompson RM, Dean DM, Goldberg S, Kwasny MJ, Langman CB, Janicki JA. Vitamin D Insufficiency and Fracture Risk in Urban Children. J Pediatr Orthop. 2017 Sep;37(6):368-373. doi: 10.1097/BPO.0000000000000697.
Reference Type
BACKGROUND
Huber AM, Ward LM. The impact of underlying disease on fracture risk and bone mineral density in children with rheumatic disorders: A review of current literature. Semin Arthritis Rheum. 2016 Aug;46(1):49-63. doi: 10.1016/j.semarthrit.2016.02.003. Epub 2016 Feb 26.
Reference Type
BACKGROUND
Mohammadi Z, Fayyazbakhsh F, Ebrahimi M, Amoli MM, Khashayar P, Dini M, Zadeh RN, Keshtkar A, Barikani HR. Association between vitamin D receptor gene polymorphisms (Fok1 and Bsm1) and osteoporosis: a systematic review. J Diabetes Metab Disord. 2014 Oct 17;13(1):98. doi: 10.1186/s40200-014-0098-x. eCollection 2014.
Reference Type
BACKGROUND
Haussler MR, Whitfield GK, Haussler CA, Hsieh JC, Thompson PD, Selznick SH, Dominguez CE, Jurutka PW. The nuclear vitamin D receptor: biological and molecular regulatory properties revealed. J Bone Miner Res. 1998 Mar;13(3):325-49. doi: 10.1359/jbmr.1998.13.3.325. No abstract available.
Reference Type
BACKGROUND
Deluca HF, Cantorna MT. Vitamin D: its role and uses in immunology. FASEB J. 2001 Dec;15(14):2579-85. doi: 10.1096/fj.01-0433rev.
Reference Type
BACKGROUND
Szymczak I, Pawliczak R. The Active Metabolite of Vitamin D3 as a Potential Immunomodulator. Scand J Immunol. 2016 Feb;83(2):83-91. doi: 10.1111/sji.12403.
Reference Type
BACKGROUND
Hii CS, Ferrante A. The Non-Genomic Actions of Vitamin D. Nutrients. 2016 Mar 2;8(3):135. doi: 10.3390/nu8030135.
Reference Type
BACKGROUND
Holick MF. High prevalence of vitamin D inadequacy and implications for health. Mayo Clin Proc. 2006 Mar;81(3):353-73. doi: 10.4065/81.3.353.
Reference Type
BACKGROUND
Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
Reference Type
BACKGROUND
Ryan LM, Brandoli C, Freishtat RJ, Wright JL, Tosi L, Chamberlain JM. Prevalence of vitamin D insufficiency in African American children with forearm fractures: a preliminary study. J Pediatr Orthop. 2010 Mar;30(2):106-9. doi: 10.1097/BPO.0b013e3181d076a3.
Reference Type
BACKGROUND
Karpiński M, Popko J, Żelazowska-Rutkowska B.Prevalence of vitamin D insufficiency in children with low-energy fractures. Endokrynol Ped 2:9-16, 2011.
Reference Type
BACKGROUND
Schilling S, Wood JN, Levine MA, Langdon D, Christian CW. Vitamin D status in abused and nonabused children younger than 2 years old with fractures. Pediatrics. 2011 May;127(5):835-41. doi: 10.1542/peds.2010-0533. Epub 2011 Apr 11.
Reference Type
BACKGROUND
Bond L, Clements J, Bertalli N, Evans-Whipp T, McMorris BJ, Patton GC, Toumbourou JW, Catalano RF. A comparison of self-reported puberty using the Pubertal Development Scale and the Sexual Maturation Scale in a school-based epidemiologic survey. J Adolesc. 2006 Oct;29(5):709-20. doi: 10.1016/j.adolescence.2005.10.001. Epub 2005 Dec 1.
Reference Type
BACKGROUND
Carskadon MA, Acebo C. A self-administered rating scale for pubertal development. J Adolesc Health. 1993 May;14(3):190-5. doi: 10.1016/1054-139x(93)90004-9.
Reference Type
BACKGROUND
Dick MD, Rose JR, Pulkkinen L, . Kaprio J. Measuring puberty and understanding its impact: A longitudinal study of adolescent twins. J Youth Adolesc 30:385-399, 2001.
Reference Type
BACKGROUND
Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
Reference Type
BACKGROUND
Cole TJ. The evidential value of developmental age imaging for assessing age of majority. Ann Hum Biol. 2015;42(4):379-88. doi: 10.3109/03014460.2015.1031826. Epub 2015 Jul 2.
Reference Type
BACKGROUND
Gyorffy B, Vasarhelyi B, Krikovszky D, Madacsy L, Tordai A, Tulassay T, Szabo A. Gender-specific association of vitamin D receptor polymorphism combinations with type 1 diabetes mellitus. Eur J Endocrinol. 2002 Dec;147(6):803-8. doi: 10.1530/eje.0.1470803.
Reference Type
BACKGROUND
Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child. 1969 Jun;44(235):291-303. doi: 10.1136/adc.44.235.291. No abstract available.
Reference Type
BACKGROUND
Marshall WA, Tanner JM. Variations in the pattern of pubertal changes in boys. Arch Dis Child. 1970 Feb;45(239):13-23. doi: 10.1136/adc.45.239.13.
Reference Type
BACKGROUND
Lyons RA, Sellstrom E, Delahunty AM, Loeb M, Varilo S. Incidence and cause of fractures in European districts. Arch Dis Child. 2000 Jun;82(6):452-5. doi: 10.1136/adc.82.6.452.
Reference Type
BACKGROUND
Hansson G, Hirsch G. Fractures in children. J Pediatr Orthop B. 1997 Apr;6(2):77-8. doi: 10.1097/01202412-199704000-00001. No abstract available.
Reference Type
BACKGROUND
Goulding A, Jones IE, Taylor RW, Manning PJ, Williams SM. More broken bones: a 4-year double cohort study of young girls with and without distal forearm fractures. J Bone Miner Res. 2000 Oct;15(10):2011-8. doi: 10.1359/jbmr.2000.15.10.2011.
Reference Type
BACKGROUND
Goulding A, Grant AM, Williams SM. Bone and body composition of children and adolescents with repeated forearm fractures. J Bone Miner Res. 2005 Dec;20(12):2090-6. doi: 10.1359/JBMR.050820. Epub 2005 Aug 22.
Reference Type
BACKGROUND
Goulding A, Rockell JE, Black RE, Grant AM, Jones IE, Williams SM. Children who avoid drinking cow's milk are at increased risk for prepubertal bone fractures. J Am Diet Assoc. 2004 Feb;104(2):250-3. doi: 10.1016/j.jada.2003.11.008.
Reference Type
BACKGROUND
Clark EM, Tobias JH, Ness AR. Association between bone density and fractures in children: a systematic review and meta-analysis. Pediatrics. 2006 Feb;117(2):e291-7. doi: 10.1542/peds.2005-1404.
Reference Type
BACKGROUND
Ferrari SL, Chevalley T, Bonjour JP, Rizzoli R. Childhood fractures are associated with decreased bone mass gain during puberty: an early marker of persistent bone fragility? J Bone Miner Res. 2006 Apr;21(4):501-7. doi: 10.1359/jbmr.051215. Epub 2006 Apr 5.
Reference Type
BACKGROUND
Abrams SA, Griffin IJ, Hawthorne KM, Chen Z, Gunn SK, Wilde M, Darlington G, Shypailo RJ, Ellis KJ. Vitamin D receptor Fok1 polymorphisms affect calcium absorption, kinetics, and bone mineralization rates during puberty. J Bone Miner Res. 2005 Jun;20(6):945-53. doi: 10.1359/JBMR.050114. Epub 2005 Jan 31.
Reference Type
BACKGROUND
Macdonald HM, McGuigan FE, Stewart A, Black AJ, Fraser WD, Ralston S, Reid DM. Large-scale population-based study shows no evidence of association between common polymorphism of the VDR gene and BMD in British women. J Bone Miner Res. 2006 Jan;21(1):151-62. doi: 10.1359/JBMR.050906. Epub 2005 Sep 12.
Reference Type
BACKGROUND
Ji GR, Yao M, Sun CY, Li ZH, Han Z. BsmI, TaqI, ApaI and FokI polymorphisms in the vitamin D receptor (VDR) gene and risk of fracture in Caucasians: a meta-analysis. Bone. 2010 Sep;47(3):681-6. doi: 10.1016/j.bone.2010.06.024. Epub 2010 Jun 28.
Reference Type
BACKGROUND
Uitterlinden AG, Ralston SH, Brandi ML, Carey AH, Grinberg D, Langdahl BL, Lips P, Lorenc R, Obermayer-Pietsch B, Reeve J, Reid DM, Amedei A, Bassiti A, Bustamante M, Husted LB, Diez-Perez A, Dobnig H, Dunning AM, Enjuanes A, Fahrleitner-Pammer A, Fang Y, Karczmarewicz E, Kruk M, van Leeuwen JP, Mavilia C, van Meurs JB, Mangion J, McGuigan FE, Pols HA, Renner W, Rivadeneira F, van Schoor NM, Scollen S, Sherlock RE, Ioannidis JP; APOSS Investigators; EPOS Investigators; EPOLOS Investigators; FAMOS Investigators; LASA Investigators; Rotterdam Study Investigators; GENOMOS Study. The association between common vitamin D receptor gene variations and osteoporosis: a participant-level meta-analysis. Ann Intern Med. 2006 Aug 15;145(4):255-64. doi: 10.7326/0003-4819-145-4-200608150-00005.
Reference Type
BACKGROUND
Uitterlinden AG, Fang Y, Van Meurs JB, Pols HA, Van Leeuwen JP. Genetics and biology of vitamin D receptor polymorphisms. Gene. 2004 Sep 1;338(2):143-56. doi: 10.1016/j.gene.2004.05.014.
Reference Type
BACKGROUND
Fang Y, Rivadeneira F, van Meurs JB, Pols HA, Ioannidis JP, Uitterlinden AG. Vitamin D receptor gene BsmI and TaqI polymorphisms and fracture risk: a meta-analysis. Bone. 2006 Oct;39(4):938-45. doi: 10.1016/j.bone.2006.04.016.
Reference Type
BACKGROUND
Horst-Sikorska W, Kalak R, Wawrzyniak A, Marcinkowska M, Celczynska-Bajew L, Slomski R. Association analysis of the polymorphisms of the VDR gene with bone mineral density and the occurrence of fractures. J Bone Miner Metab. 2007;25(5):310-9. doi: 10.1007/s00774-007-0769-5. Epub 2007 Aug 25.
Reference Type
BACKGROUND
Bener A, Al-Ali M, Hoffmann GF. Vitamin D deficiency in healthy children in a sunny country: associated factors. Int J Food Sci Nutr. 2009;60 Suppl 5:60-70. doi: 10.1080/09637480802400487. Epub 2008 Oct 22.
Reference Type
BACKGROUND
Steele B, Serota A, Helfet DL, Peterson M, Lyman S, Lane JM. Vitamin D deficiency: a common occurrence in both high-and low-energy fractures. HSS J. 2008 Sep;4(2):143-8. doi: 10.1007/s11420-008-9083-6. Epub 2008 Jul 19.
Reference Type
BACKGROUND
Peters BS, dos Santos LC, Fisberg M, Wood RJ, Martini LA. Prevalence of vitamin D insufficiency in Brazilian adolescents. Ann Nutr Metab. 2009;54(1):15-21. doi: 10.1159/000199454. Epub 2009 Feb 5.
Reference Type
BACKGROUND
Turner AG, Anderson PH, Morris HA. Vitamin D and bone health. Scand J Clin Lab Invest Suppl. 2012;243:65-72. doi: 10.3109/00365513.2012.681963.
Reference Type
BACKGROUND
Becker C, Crow S, Toman J, Lipton C, McMahon DJ, Macaulay W, Siris E. Characteristics of elderly patients admitted to an urban tertiary care hospital with osteoporotic fractures: correlations with risk factors, fracture type, gender and ethnicity. Osteoporos Int. 2006;17(3):410-6. doi: 10.1007/s00198-005-0001-1. Epub 2005 Nov 8.
Reference Type
BACKGROUND
Glowacki J, Hurwitz S, Thornhill TS, Kelly M, LeBoff MS. Osteoporosis and vitamin-D deficiency among postmenopausal women with osteoarthritis undergoing total hip arthroplasty. J Bone Joint Surg Am. 2003 Dec;85(12):2371-7. doi: 10.2106/00004623-200312000-00015.
Reference Type
BACKGROUND
Janssen HC, Samson MM, Verhaar HJ. Vitamin D deficiency, muscle function, and falls in elderly people. Am J Clin Nutr. 2002 Apr;75(4):611-5. doi: 10.1093/ajcn/75.4.611.
Reference Type
BACKGROUND
Hitz MF, Jensen JE, Eskildsen PC. Bone mineral density and bone markers in patients with a recent low-energy fracture: effect of 1 y of treatment with calcium and vitamin D. Am J Clin Nutr. 2007 Jul;86(1):251-9. doi: 10.1093/ajcn/86.1.251.
Reference Type
BACKGROUND
Pawley N, Bishop NJ. Prenatal and infant predictors of bone health: the influence of vitamin D. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1748S-51S. doi: 10.1093/ajcn/80.6.1748S.
Reference Type
BACKGROUND
Lehtonen-Veromaa MK, Mottonen TT, Nuotio IO, Irjala KM, Leino AE, Viikari JS. Vitamin D and attainment of peak bone mass among peripubertal Finnish girls: a 3-y prospective study. Am J Clin Nutr. 2002 Dec;76(6):1446-53. doi: 10.1093/ajcn/76.6.1446.
Reference Type
BACKGROUND
Li K, Shi Q, Yang L, Li X, Liu L, Wang L, Li Q, Wang G, Li CY, Gao TW. The association of vitamin D receptor gene polymorphisms and serum 25-hydroxyvitamin D levels with generalized vitiligo. Br J Dermatol. 2012 Oct;167(4):815-21. doi: 10.1111/j.1365-2133.2012.11132.x.
Reference Type
BACKGROUND
Santos BR, Mascarenhas LP, Satler F, Boguszewski MC, Spritzer PM. Vitamin D deficiency in girls from South Brazil: a cross-sectional study on prevalence and association with vitamin D receptor gene variants. BMC Pediatr. 2012 Jun 8;12:62. doi: 10.1186/1471-2431-12-62.
Reference Type
BACKGROUND
Clark EM, Ness AR, Tobias JH. Vigorous physical activity increases fracture risk in children irrespective of bone mass: a prospective study of the independent risk factors for fractures in healthy children. J Bone Miner Res. 2008 Jul;23(7):1012-22. doi: 10.1359/jbmr.080303.
Reference Type
BACKGROUND
Manias K, McCabe D, Bishop N. Fractures and recurrent fractures in children; varying effects of environmental factors as well as bone size and mass. Bone. 2006 Sep;39(3):652-7. doi: 10.1016/j.bone.2006.03.018. Epub 2006 Jun 12.
Reference Type
BACKGROUND
Landin LA. Fracture patterns in children. Analysis of 8,682 fractures with special reference to incidence, etiology and secular changes in a Swedish urban population 1950-1979. Acta Orthop Scand Suppl. 1983;202:1-109.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MUBialystok
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Vitamin D3 Supplementation and Stress Fracture Occurrence in High-Risk Collegiate Athletes
NCT03395171
COMPLETED
NA
Vitamin D Status and Dose Response in Infants
NCT01042561
COMPLETED
NA
Seasonal Variations in Serum 25-hydroxy Vitamin-D Levels in a Swedish Cohort
NCT02136407
COMPLETED
Vitamin D Serum Concentrations & Supplementation in Children With Cerebral Palsy
NCT01926808
COMPLETED
Calcium (ca),Phosphorus( P) and 25-hydroxyvitamin D(25OHD)] in Infants Born ≤ 32 PMA Gestational Weeks (GA)
NCT03691896
UNKNOWN
PHASE3
Vitamin D and Bone Homeostasis in Ortho Polytrauma Patients
NCT03066817
SUSPENDED
PHASE1/PHASE2
Vitamin D Deficiency and Low Bone Mineral Content in Children
NCT00756899
COMPLETED
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy
NCT00692120
COMPLETED
NA
Vitamin D Supplementation in Children
NCT03402698
COMPLETED
NA
The Effect of Hypovitaminosis D and Vitamin D Supplementation on Fracture Nonunion Rates
NCT01691833
COMPLETED
NA
Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children
NCT00944606
WITHDRAWN
NA
Effect of Vitamin D3 Supplementation in Children From 12 to 30 Months of Age.
NCT03544671
COMPLETED
NA
Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta
NCT01713231
COMPLETED
PHASE4
Pilot Pharmacokinetic Study of Daily Versus Monthly High-Dose Cholecalciferol Supplementation
NCT01079923
COMPLETED
NA
The Variability of 25-hydroxyvitamin D Response From Crystalline 25-hydroxyvitamin D3
NCT01633658
WITHDRAWN
NA
Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial
NCT02452762
COMPLETED
PHASE2
Effects of Oral Cholecalciferol (Vitamin D3) on Bone Health, Neuromuscular Function, and Quality of Life in Adults With Chronic Kidney Disease
NCT00511225
COMPLETED
NA
Relative Efficacy of Vitamins D2 and D3 in Adult Humans
NCT01139840
COMPLETED
NA
Vitamin D Supplementation and Tibia Fracture. Does it Improve Healing Rate?
NCT03232216
UNKNOWN
NA
Vitamin D Deficiency and Replacement on Pulmonary and Endocrine Function in SCI
NCT02099955
COMPLETED
PHASE1/PHASE2
Effect of Different Vitamin D Vitamers on Vitamin D Status
NCT02860663
COMPLETED
NA
Vitamin D Repletion in Primary Hyperparathyroidism
NCT01306656
COMPLETED
PHASE4
Monitored vs Standard Supplementation of Vitamin D in Preterm Infants
NCT03087149
COMPLETED
NA
A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia
NCT01274104
WITHDRAWN
PHASE1
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls
NCT00267540
COMPLETED
NA