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Association Between Vitamin D Receptor Polymorphism and Serum Vitamin D Levels in Children With Low-Energy Fractures

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ClinicalTrials.gov Identifier: NCT02805647
Recruitment Status : Completed
First Posted : June 20, 2016
Results First Posted : November 19, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborators:
American Medical Holdings Inc., Staten Island, NY 10314 USA
School of Pharmacy, Creighton University, Omaha, NE 68178 USA
Information provided by (Responsible Party):
Michal Karpinski, Medical University of Bialystok

Brief Summary:
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.

Condition or disease
Vitamin D Receptor Defect

Detailed Description:

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

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Study Type : Observational
Actual Enrollment : 222 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Association Between Vitamin D Receptor Polymorphism and Serum Vitamin D Levels in Children With Low-Energy Fractures
Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures Vitamin D
Drug Information available for: Vitamin D

Group/Cohort
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
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



Primary Outcome Measures :
  1. Vitamin D Status; VDR Status [ Time Frame: We measured Vitamin D status at the time of admission - at the time of fracture ]
    Serum concentrations of total vitamin D; VDR polymorphism test


Biospecimen Retention:   Samples With DNA
Whole blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study Group: Healthy children with low energy fractures Control group: Healthy children without fractures
Criteria

Inclusion Criteria:

  • low-energy 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805647


Locations
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Poland
Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Bialystok, Poland, 15-274
Sponsors and Collaborators
Medical University of Bialystok
American Medical Holdings Inc., Staten Island, NY 10314 USA
School of Pharmacy, Creighton University, Omaha, NE 68178 USA
Investigators
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Principal Investigator: Michał Karpiński, MD Department of Pediatric Orthopedics and Traumatology Medical University of Bialystok
Publications of Results:
Other Publications:
Karpiński M, Popko J, Żelazowska-Rutkowska B.Prevalence of vitamin D insufficiency in children with low-energy fractures. Endokrynol Ped 2:9-16, 2011.
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.
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. Erratum in: Ann Intern Med. 2006 Dec 19;145(12):936. Amidei, Antonietta [corrected to Amedei, Antonietta].

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Responsible Party: Michal Karpinski, MD, Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT02805647    
Other Study ID Numbers: MUBialystok
First Posted: June 20, 2016    Key Record Dates
Results First Posted: November 19, 2019
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Michal Karpinski, Medical University of Bialystok:
25-Hydroxy-vitamin D, children, bone fractures, vitamin D receptor polymorphism
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries