Vitamin D DeficiencyVIPNCT00909454
Vitamin D Supplement Study for Adolescents
A study testing 2000 IU Vitamin D3 daily supplement and 400 IU Vitamin D3 supplement in people with Vitamin D Deficiency and Overweight, run by Augusta University at 1 site in United States.
Trial summary
The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Overweight, Obesity
- What is being tested?
- 2000 IU Vitamin D3 daily supplement and 400 IU Vitamin D3 supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2009
- 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 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy African American Adolescents
Who cannot join
- Hypertension
- Pregnancy
- Medications that affect study outcome measures
- Use of other vitamin and/or mineral supplement or herbal supplements
- Individuals of other races
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Prevention Institute at Medical College of Georgia
Augusta, Georgia, 30912
About this study
Official title: V.I.P. Feasibility Study (Vitamin D Intake Project)
The purpose of this study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.
Read the detailed description
To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.
To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.
- Conditions
- Vitamin D Deficiency, Overweight, Obesity
- Being tested
- 2000 IU Vitamin D3 daily supplement, 400 IU Vitamin D3 supplement
- Keywords
- Vitamin D deficiency, Adolescents, African Americans, Overweight, Obesity
- Medical subject headings
- Vitamin D Deficiency, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2000 IU Vitamin D3 daily supplementDietary supplement
Also called NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516
2000 IU vitamin D3 supplement to be taken once daily over 4 months
400 IU Vitamin D3 supplementDietary supplement
Also called NatureMade D Vitamin 400 IU List No. 1688
400 IU Vitamin D3 supplement to be taken daily over 4 months
| Study group | Role | What they receive |
|---|---|---|
| Daily 2000 IU vitamin D supplement | Experimental | Not described Receives: Dietary Supplement: 2000 IU Vitamin D3 daily supplement |
| Daily Vitamin D supplement 400 IU | Active comparator | Not described Receives: Dietary Supplement: 400 IU Vitamin D3 supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma 25-OH D level
Measured: 3-4 months from baseline to post-testing
Secondary outcomes (1)
Blood pressure
Measured: 3-4 months from baseline to post-testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbin Dong, Augusta University
- Investigators
- Yanbin Dong, MD, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909454
- Sponsor's protocol ID
- 0901159
- Acronym
- VIP
- Status last verified
- Oct 2011
- First submitted
- 22 May 2009
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Dong Y, Stallmann-Jorgensen IS, Pollock NK, Harris RA, Keeton D, Huang Y, Li K, Bassali R, Guo DH, Thomas J, Pierce GL, White J, Holick MF, Zhu H. A 16-week randomized clinical trial of 2000 international units daily vitamin D3 supplementation in black youth: 25-hydroxyvitamin D, adiposity, and arterial stiffness. J Clin Endocrinol Metab. 2010 Oct;95(10):4584-91. doi: 10.1210/jc.2010-0606. Epub 2010 Jul 21.
PubMed 20660028
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V.I.P. Feasibility Study (Vitamin D Intake Project)
- ClinicalTrials.gov ID
- NCT00909454
- Acronym / sponsor ID
- VIP / 0901159
- Conditions
- Vitamin D Deficiency, Overweight, Obesity
- Keywords
- Vitamin D deficiency, Adolescents, African Americans, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 May 2009 (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 study is to determine if 14-19 year old African American adolescents are able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.
Detailed description
To determine the feasibility of African American teenagers taking a daily vitamin D supplement over a 4 month period in terms of compliance and practical implementation.
To determine the differences in response in blood 25-OH D level between those randomly assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are differences in blood 25-OH D level response depending on subject gender and overweight/obese versus healthy-weight status.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily 2000 IU vitamin D supplement | Experimental | Dietary Supplement: 2000 IU Vitamin D3 daily supplement |
| Daily Vitamin D supplement 400 IU | Active comparator | Dietary Supplement: 400 IU Vitamin D3 supplement |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy African American Adolescents
Key exclusion criteria (5 listed)
- Hypertension
- Pregnancy
- Medications that affect study outcome measures
- Use of other vitamin and/or mineral supplement or herbal supplements
- Individuals of other races
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 |
|---|---|---|
| 2000 IU Vitamin D3 daily supplementAlso: NatureMade Maximum Strength D Vitamin 2000 IU List NO. 25162000 IU vitamin D3 supplement to be taken once daily over 4 months | Dietary supplement | Daily 2000 IU vitamin D supplement |
| 400 IU Vitamin D3 supplementAlso: NatureMade D Vitamin 400 IU List No. 1688400 IU Vitamin D3 supplement to be taken daily over 4 months | Dietary supplement | Daily Vitamin D supplement 400 IU |
Primary outcome
Plasma 25-OH D level
Time frame: 3-4 months from baseline to post-testing
1 secondary outcome
Blood pressure
Time frame: 3-4 months from baseline to post-testing
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 17 Oct 2011.
- Derived from this study: PubMed 20660028Dong Y, Stallmann-Jorgensen IS, Pollock NK, Harris RA, Keeton D, Huang Y, Li K, Bassali R, Guo DH, Thomas J, Pierce GL, White J, Holick MF, Zhu H. A 16-week randomized clinical trial of 2000 international units daily vitamin D3 supplementation in black youth: 25-hydroxyvitamin D, adiposity, and arterial stiffness. J Clin Endocrinol Metab. 2010 Oct;95(10):4584-91. doi: 10.1210/jc.2010-0606. Epub 2010 Jul 21.
Related trials for Vitamin D Deficiency
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
RecruitingPhase 3
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
Vision Loss Night, Vision Disorders
Active, not recruitingPhase 3
The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients
Critical Illness, Vitamin D Deficiency
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.
Yanbin Dong, MD, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2000 IU Vitamin D3 daily supplement and 400 IU Vitamin D3 supplement in people with Vitamin D Deficiency and Overweight, run by Augusta University 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 1 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 17 Oct 2011. 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?
Plasma 25-OH D level (time frame: 3-4 months from baseline to post-testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00909454, which also lists 1 linked publication.
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 17 Oct 2011; AzTrials last refreshed its copy on 2 Nov 2026.