Vitamin D DeficiencyVDSNCT00756899
Vitamin D Deficiency and Low Bone Mineral Content in Children
An observational study of Vitamin D Deficiency and Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Obesity
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Prepubertal children
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D Deficiency, Obesity
- Keywords
- Vitamin D deficiency, insulin resistance, obesity, bone
- Medical subject headings
- Vitamin D Deficiency, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese | Chilren with BMI of >95th percentile | |
| Non-obese | Children with BMI of <85th percentile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral content
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin U. Nwosu, University of Massachusetts, Worcester
- Investigators
- Benjamin U Nwosu, MD, Principal investigator, University of Massachusetts, WorcesterCarol A Cicarrelli, RN, Study director, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756899
- Sponsor's protocol ID
- H-12795
- Acronym
- VDS
- Status last verified
- Oct 2012
- First submitted
- 18 Sep 2008
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Vitamin D Deficiency and Low Bone Mineral Content in Children
- ClinicalTrials.gov ID
- NCT00756899
- Acronym / sponsor ID
- VDS / H-12795
- Conditions
- Vitamin D Deficiency, Obesity
- Keywords
- Vitamin D deficiency, insulin resistance, obesity, bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | – | –Chilren with BMI of >95th percentile |
| Non-obese | – | –Children with BMI of <85th percentile |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Prepubertal children
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone mineral content
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin U Nwosu, MD principal investigator
University of Massachusetts, Worcester
Carol A Cicarrelli, RN study director
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Obesity, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral content (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.