Vitamin D Deficiency and Low Bone Mineral Content in Children

The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00756899

Acronym

VDS

Enrollment

Registered

2008-09-22

Start date

2008-07-31

Completion date

2012-05-31

Last updated

2012-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Vitamin D Deficiency

Keywords

Vitamin D deficiency, insulin resistance, obesity, bone

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bone mineral content	Baseline

Countries

United States

Outcome results