Vitamin D Deficiency and Low Bone Mineral Content in Children (VDS)
The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children
The Vitamin D study is designed to investigate the effect of body fat mass on vitamin D levels in children. Earlier studies have shown that individuals with increased fat mass may have low vitamin D levels.
Our specific hypothesis states that children with increased fat mass will have lower blood levels of vitamin D when compared to non-obese children.Since vitamin D is the primary hormone for bone mineralization in humans, low levels of vitamin D could lead to decreased bone mineral content in these children.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Fifty prepubertal male and female children of ages between 3-12 years will participate in this study. Of these, 25 obese children will be enrolled in the study group, and 25 non-obese children will serve as controls.
All subjects will fill out a comprehensive mineral intake questionnaire as part of the study to ensure adequate calcium intake prior to the study.
All subjects will collect a first morning urine sample for calcium, creatinine, and NTX.
Fasting blood samples will be drawn for the following analytes: 25-hydroxyvitamin D, 1, 25-dihydroxyvitamin D, intact PTH, calcium, phosphorus, magnesium, osteocalcin, insulin, c-peptide, fasting blood glucose, leptin, and adiponectin.
Bone Mineral Content will be evaluated in 16 obese subjects with vitamin D level of < 30 nmol/L.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Medical School
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- General: Prepubertal children (males, with testicular volume of ≤ 3 cc, and girls with Tanner 1 breast) of ages 7-11 years will be enrolled in the study.
- Study group: Subjects with a BMI of > 95th percentile for age and sex.
- Control group: All control subjects will have a BMI of < 85th percentile for age and sex.
Exclusion Criteria:
- known metabolic or genetic diseases resulting in obesity such as severe hypothyroidism, pseudohypoparathyroidism, or Cushing's disease
- diabetes mellitus
- subjects on lipid lowering medications
- subjects on medications known to impact body weight or calcium homeostasis
- subjects with a history of recent significant weight loss or gain
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Obese
Chilren with BMI of >95th percentile
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Non-obese
Children with BMI of <85th percentile
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Knoglemineralindhold
Tidsramme: Baseline
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Baseline
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Benjamin U Nwosu, MD, University of Massachusetts, Worcester
- Studieleder: Carol A Cicarrelli, RN, University of Massachusetts, Worcester
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-12795
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