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Completed

NCT Number: NCT00756899

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Body Weight Deficiency Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Bone mineral content

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

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

Acronym: VDS

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2008
Registry last updated
Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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