Vitamin D SupplementationNCT01126671
Vitamin D Supplementation in Healthy Adolescents
A study testing Supplemental Vitamin D in people with Vitamin D Supplementation, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Supplementation
- What is being tested?
- Supplemental Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 11-18 years old
- healthy
Who cannot join
- chronic disease
- use of medication known to effect bone or vitamin D metabolism
- abnormal vitamin D or calcium at screening
- pregnant
- body mass index <5% or >95%
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: Clinical Trial of Vitamin D Supplementation in Healthy Adolescents
This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.
Read the detailed description
Vitamin D deficiency is a common problem. Currently, data do not support a recommended vitamin D supplementation dose for health adolescents to maintain normal vitamin D levels. This double blind, randomized controlled 12 week trial compares the use of two supplemental doses of vitamin D in this population.
- Conditions
- Vitamin D Supplementation
- Being tested
- Supplemental Vitamin D
- Keywords
- vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental Vitamin DDrug
Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Vitamin D | Active comparator | Subjects are randomized to take 200 IU vitamin D3 daily in this arm. Receives: Drug: Supplemental Vitamin D |
| High Dose Vitamin D | Active comparator | Subjects are randomized to take 1000 IU vitamin D3 daily in this arm. Receives: Drug: Supplemental Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline 25 Hydroxy Vitamin D (25OHD) Levels
25OHD will be drawn at baseline prior to starting vitamin D supplementation.
Measured: Baseline
Follow-up 25OHD Levels
After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.
Measured: 12 weeks
Secondary outcomes (2)
Baseline Assessment of Bone Markers
Bone specific alkaline phosphatase, CTx, and osteocalcin will be assessed at baseline prior to subjects starting vitamin D supplementation
Measured: Baseline
Assessment of Bone Markers at Follow-up
After 11 weeks of vitamin D supplementation bone specific alkaline phosphatase, osteocalcin, and CTx will be repeated to see response to therapy.
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 posted20 May 2010 (estimated)
- Study startNov 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D SupplementationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Pitts, Boston Children's Hospital
- Investigators
- Melissa Putman, MD, Principal investigator, Childrens Hospital, BostonSarah Pitts, MD, Principal investigator, Childrens Hospital, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126671
- Sponsor's protocol ID
- 08-06-0271
- Status last verified
- May 2018
- First submitted
- 18 May 2010
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Putman MS, Pitts SA, Milliren CE, Feldman HA, Reinold K, Gordon CM. A randomized clinical trial of vitamin D supplementation in healthy adolescents. J Adolesc Health. 2013 May;52(5):592-8. doi: 10.1016/j.jadohealth.2012.10.270. Epub 2012 Dec 23.
PubMed 23608721
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Vitamin D Supplementation in Healthy Adolescents
- ClinicalTrials.gov ID
- NCT01126671
- Acronym / sponsor ID
- 08-06-0271
- Conditions
- Vitamin D Supplementation
- Keywords
- vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Posted 19 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double blind, randomized controlled trial compares two supplemental doses of vitamin D in health adolescents.
Detailed description
Vitamin D deficiency is a common problem. Currently, data do not support a recommended vitamin D supplementation dose for health adolescents to maintain normal vitamin D levels. This double blind, randomized controlled 12 week trial compares the use of two supplemental doses of vitamin D in this population.
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 |
|---|---|---|
| Low Dose Vitamin D | Active comparator | Drug: Supplemental Vitamin DSubjects are randomized to take 200 IU vitamin D3 daily in this arm. |
| High Dose Vitamin D | Active comparator | Drug: Supplemental Vitamin DSubjects are randomized to take 1000 IU vitamin D3 daily in this arm. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 11-18 years old
- healthy
Key exclusion criteria (5 listed)
- chronic disease
- use of medication known to effect bone or vitamin D metabolism
- abnormal vitamin D or calcium at screening
- pregnant
- body mass index <5% or >95%
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 |
|---|---|---|
| Supplemental Vitamin DSubjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after. | Drug | High Dose Vitamin D, Low Dose Vitamin D |
Primary outcome
Baseline 25 Hydroxy Vitamin D (25OHD) Levels
Time frame: Baseline
25OHD will be drawn at baseline prior to starting vitamin D supplementation.
Follow-up 25OHD Levels
Time frame: 12 weeks
After 11weeks of treatment, repeat 25OHD levels will be drawn to assess subject response to vitamin D supplementation.
2 secondary outcomes
Baseline Assessment of Bone Markers
Time frame: Baseline
Assessment of Bone Markers at Follow-up
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23608721Putman MS, Pitts SA, Milliren CE, Feldman HA, Reinold K, Gordon CM. A randomized clinical trial of vitamin D supplementation in healthy adolescents. J Adolesc Health. 2013 May;52(5):592-8. doi: 10.1016/j.jadohealth.2012.10.270. Epub 2012 Dec 23.
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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.
Melissa Putman, MD principal investigator
Childrens Hospital, Boston
Sarah Pitts, MD principal investigator
Childrens Hospital, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemental Vitamin D in people with Vitamin D Supplementation, run by Boston Children's Hospital 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 2 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 4 Jun 2018. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline 25 Hydroxy Vitamin D (25OHD) Levels (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT01126671, 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 4 Jun 2018.