Hypovitaminosis DNCT00944606
Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children
A study testing Vitamin D in people with Hypovitaminosis D, run by University of New Mexico at 1 site in United States.
Trial summary
Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain. Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis D
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2011
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ages 5-14
- healthy
- vague musculoskeletal pain without diagnosis
Who cannot join
- medications (steroids, seizure medications, birth control pills or shot)
- endocrinopathies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico General Clinical Research Center
Albuquerque, New Mexico, 87102
About this study
Official title: Vitamin D vs Placebo in the Treatment of Vague Musculoskeletal Pain in Children
Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain.
Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children.
- Conditions
- Hypovitaminosis D
- Being tested
- Vitamin D, Placebo candy
- 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.
Vitamin DDietary supplement
Also called Rainbow Light
2000-3000 IU Vitamin D daily x 6 weeks
Placebo candyOther
candy gum drops
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Not described Receives: Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lessening of musculoskeletal pain level and frequency
Measured: 6 weeks
Secondary outcomes (2)
Improvement of serum 25 OH Vitamin D level
Measured: 6 weeks
Decline of serum parathyroid hormone levels
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: inability to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis DStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Szalay, University of New Mexico
- Investigators
- Elizabeth A Szalay, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944606
- Sponsor's protocol ID
- HRRC 09-167
- Status last verified
- Feb 2012
- First submitted
- 21 Jul 2009
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D vs Placebo in the Treatment of Vague Musculoskeletal Pain in Children
- ClinicalTrials.gov ID
- NCT00944606
- Acronym / sponsor ID
- HRRC 09-167
- Conditions
- Hypovitaminosis D
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to recruit subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 Jul 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.
Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain.
Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Other: Placebo candy |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ages 5-14
- healthy
- vague musculoskeletal pain without diagnosis
Key exclusion criteria (2 listed)
- medications (steroids, seizure medications, birth control pills or shot)
- endocrinopathies
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 |
|---|---|---|
| Vitamin DAlso: Rainbow Light2000-3000 IU Vitamin D daily x 6 weeks | Dietary supplement | Vitamin D |
| Placebo candycandy gum drops | Other | Placebo |
Primary outcome
Lessening of musculoskeletal pain level and frequency
Time frame: 6 weeks
2 secondary outcomes
Improvement of serum 25 OH Vitamin D level
Time frame: 6 weeks
Decline of serum parathyroid hormone levels
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 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.
Elizabeth A Szalay, MD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Hypovitaminosis D, run by University of New Mexico 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 2 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: withdrawn, as of the sponsor's last update on 1 Mar 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Lessening of musculoskeletal pain level and frequency (time frame: 6 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 1 Mar 2012.