Vitamin D DeficiencyNCT01546103
Vitamin D3 Supplementation Pilot Study
A study testing Cholecalciferol in people with Vitamin D Deficiency, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this research study is to determine whether taking vitamin D, every day, over a 12 week period will improve the vitamin D status, risks for poor heart health, risks for developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers with low vitamin D levels. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2012
- Phase
- Interventional
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- African American
- Obese [body mass index (BMI) greater than or equal to 95th percentile for age and sex]
- Pubertal (Tanner Stage greater than 1)
- 25OHD less than 20 ng/mL (for treatment phase); if 25OHD is greater than or equal to 20 ng/mL, only baseline data will be obtained.
- Committed to adherence to supplementation and study completion
Who cannot join
- Pregnancy
- Chronic medical conditions or medications use that can affect growth, nutrition, bone health, vitamin D metabolism, glucose, or insulin sensitivity
- Known history of hypercalcemia or hypercalciuria
- Non-English speaking, as assessments are available only in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Study of Vitamin D3 Supplementation and Outcomes in Vitamin D Deficient Obese, African American Adolescents
The purpose of this research study is to determine whether taking vitamin D, every day, over a 12 week period will improve the vitamin D status, risks for poor heart health, risks for developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers with low vitamin D levels.
Read the detailed description
Vitamin D deficiency/insufficiency is common throughout the lifespan, and across all race and ethnic groups. The American Academy of Pediatrics (AAP) recently recommended supplementation dose to 400 international units (IU) daily in all children. These recommendations target rickets prevention, but address neither the vitamin D supplementation necessary to optimize bone health nor the nontraditional vitamin D roles in immune disease, insulin resistance, muscle function, and cardiovascular disease (CVD). Moreover, the AAP recommendation noted that it had little pediatric data upon which to base guidelines. The Institute of Medicine also recently published Dietary Reference Intakes for Calcium and Vitamin D: the estimated average requirement in children and adults was set at 400(IU) daily and the recommend dietary allowance was set at 600 IU daily. Data on outcomes and supplementation levels in African Americans (a population at particular risk for vitamin D deficiency) and across pediatric age ranges and body habitus types, are lacking. The Vitamin D supplementation requirement in obese, African American adolescents is particularly problematic since obesity is associated with 1) lower circulating vitamin D levels (25OHD) and 2) insulin resistance. This pilot study will examine the effect of vitamin D supplementation upon 25OHD, the serum marker of vitamin D status, in obese, African American adolescents with vitamin D deficiency. Subjects will be randomized to receive cholecalciferol 1000 IU or 5000 IU daily for 3 months. Serum 25OHD, parathyroid hormone, glucose, insulin, CVD risk markers, and measures of muscle function and pain will be obtained at baseline and post-treatment. This pilot study will provide data on serum 25OHD responses to vitamin D at doses more likely to meaningfully impact 25OHD than the current American Academy of Pediatrics (AAP) supplementation guideline. Responses to supplementation can then inform future clinical trials aimed at addressing outcomes of vitamin D replacement on insulin sensitivity and CVD risk in obese adolescents.
- Conditions
- Vitamin D Deficiency
- Being tested
- Cholecalciferol
- Keywords
- Vitamin D deficiency
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called Vitamin D
1000 IU by mouth, once daily for 3 months.
CholecalciferolDietary supplement
Also called Vitamin D
5000 IU by mouth, once daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 supplementation of 1000 IU | Active comparator | Not described Receives: Dietary Supplement: Cholecalciferol |
| Vitamin D3 supplementation of 5000 IU | Active comparator | Not described Receives: Dietary Supplement: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25OHD before and after treatment
The analysis will be an intention-to-treat method in which subjects are assumed to obtain all vitamin D supplements from the study and from no other sources, and all subjects are assumed to comply with their assigned dose and daily use. For the main contrasts of interest (5000 IU vs 1000 IU doses as well as serum 25OHD concentrations), we propose a longitudinal mixed effects model with time measurements at 0 and 12 weeks.
Measured: 12 weeks
Secondary outcomes (9)
Adiponectin level comparison
Adiponectin level comparison before and at post-treatment
Measured: 12 weeks
Lipid panel comparison
Lipid panel comparison before and at post-treatment
Measured: 12 weeks
Lipoprotein subclass particles comparison
Lipoprotein subclass particles comparison before and at post-treatment
Measured: 12 weeks
High-sensitivity C-Reactive Protein (hsCRP) comparison
High-sensitivity C-Reactive Protein (hsCRP) comparison before and at post-treatment
Measured: 12 weeks
Insulin level comparison
Insulin level comparison before and at post-treatment
Measured: 12 weeks
Total and undercarboxylated osteocalcin level comparison
Total and undercarboxylated osteocalcin level comparison before and at post-treatment
Measured: 12 weeks
Muscle strength comparison
Muscle strength comparison before and at post-treatment
Measured: 12 weeks
Musculoskeletal pain comparison
Musculoskeletal pain comparison before and at post-treatment
Measured: 12 weeks
Blood pressure comparison
Blood pressure comparison before and at post-treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 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 Children's Hospital of PhiladelphiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheela N Magge, MD, MSCE, Principal investigator, Children's Hospital of PhiladelphiaAndrea Kelly, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546103
- Sponsor's protocol ID
- 11-008075
- Status last verified
- Jan 2013
- First submitted
- 4 Jan 2012
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Vitamin D3 Supplementation and Outcomes in Vitamin D Deficient Obese, African American Adolescents
- ClinicalTrials.gov ID
- NCT01546103
- Acronym / sponsor ID
- 11-008075
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Mar 2012 (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 purpose of this research study is to determine whether taking vitamin D, every day, over a 12 week period will improve the vitamin D status, risks for poor heart health, risks for developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers with low vitamin D levels.
Detailed description
Vitamin D deficiency/insufficiency is common throughout the lifespan, and across all race and ethnic groups. The American Academy of Pediatrics (AAP) recently recommended supplementation dose to 400 international units (IU) daily in all children. These recommendations target rickets prevention, but address neither the vitamin D supplementation necessary to optimize bone health nor the nontraditional vitamin D roles in immune disease, insulin resistance, muscle function, and cardiovascular disease (CVD). Moreover, the AAP recommendation noted that it had little pediatric data upon which to base guidelines. The Institute of Medicine also recently published Dietary Reference Intakes for Calcium and Vitamin D: the estimated average requirement in children and adults was set at 400(IU) daily and the recommend dietary allowance was set at 600 IU daily. Data on outcomes and supplementation levels in African Americans (a population at particular risk for vitamin D deficiency) and across pediatric age ranges and body habitus types, are lacking. The Vitamin D supplementation requirement in obese, African American adolescents is particularly problematic since obesity is associated with 1) lower circulating vitamin D levels (25OHD) and 2) insulin resistance. This pilot study will examine the effect of vitamin D supplementation upon 25OHD, the serum marker of vitamin D status, in obese, African American adolescents with vitamin D deficiency. Subjects will be randomized to receive cholecalciferol 1000 IU or 5000 IU daily for 3 months. Serum 25OHD, parathyroid hormone, glucose, insulin, CVD risk markers, and measures of muscle function and pain will be obtained at baseline and post-treatment. This pilot study will provide data on serum 25OHD responses to vitamin D at doses more likely to meaningfully impact 25OHD than the current American Academy of Pediatrics (AAP) supplementation guideline. Responses to supplementation can then inform future clinical trials aimed at addressing outcomes of vitamin D replacement on insulin sensitivity and CVD risk in obese adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplementation of 1000 IU | Active comparator | Dietary Supplement: Cholecalciferol |
| Vitamin D3 supplementation of 5000 IU | Active comparator | Dietary Supplement: Cholecalciferol |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- African American
- Obese [body mass index (BMI) greater than or equal to 95th percentile for age and sex]
- Pubertal (Tanner Stage greater than 1)
- 25OHD less than 20 ng/mL (for treatment phase); if 25OHD is greater than or equal to 20 ng/mL, only baseline data will be obtained.
- Committed to adherence to supplementation and study completion
Key exclusion criteria (4 listed)
- Pregnancy
- Chronic medical conditions or medications use that can affect growth, nutrition, bone health, vitamin D metabolism, glucose, or insulin sensitivity
- Known history of hypercalcemia or hypercalciuria
- Non-English speaking, as assessments are available only in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: Vitamin D1000 IU by mouth, once daily for 3 months. | Dietary supplement | Vitamin D3 supplementation of 1000 IU |
| CholecalciferolAlso: Vitamin D5000 IU by mouth, once daily for 3 months. | Dietary supplement | Vitamin D3 supplementation of 5000 IU |
Primary outcome
Serum 25OHD before and after treatment
Time frame: 12 weeks
The analysis will be an intention-to-treat method in which subjects are assumed to obtain all vitamin D supplements from the study and from no other sources, and all subjects are assumed to comply with their assigned dose and daily use. For the main contrasts of interest (5000 IU vs 1000 IU doses as well as serum 25OHD concentrations), we propose a longitudinal mixed effects model with time measurements at 0 and 12 weeks.
9 secondary outcomes
Adiponectin level comparison
Time frame: 12 weeks
Lipid panel comparison
Time frame: 12 weeks
Lipoprotein subclass particles comparison
Time frame: 12 weeks
High-sensitivity C-Reactive Protein (hsCRP) comparison
Time frame: 12 weeks
Insulin level comparison
Time frame: 12 weeks
Total and undercarboxylated osteocalcin level comparison
Time frame: 12 weeks
Muscle strength comparison
Time frame: 12 weeks
Musculoskeletal pain comparison
Time frame: 12 weeks
Blood pressure comparison
Time frame: 12 weeks
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 23 Jan 2013.
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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.
Sheela N Magge, MD, MSCE principal investigator
Children's Hospital of Philadelphia
Andrea Kelly, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol in people with Vitamin D Deficiency, run by Children's Hospital of Philadelphia 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 5 inclusion and 4 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 23 Jan 2013. 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?
Serum 25OHD before and after treatment (time frame: 12 weeks). 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 23 Jan 2013; AzTrials last refreshed its copy on 31 Oct 2026.