Juvenile Rheumatoid ArthritisPhase 3NCT00570934
Supplementation With Vitamin D, Calcium or Both on Calcium Absorption and Bone Mineral Content in Children With JRA
A Phase 3 study testing Cholecalciferol, Calcium and Calcium and cholecalciferol in people with Juvenile Rheumatoid Arthritis, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Juvenile Rheumatoid Arthritis
- What is being tested?
- Cholecalciferol, Calcium and Calcium and cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1995to Feb 2002
- Phase
- Phase 3
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Juvenile Rheumatoid arthritis
Who cannot join
- Steroid use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Hospitals and clinics
Columbia, Missouri, 65203
About this study
Official title: Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis
2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.
Read the detailed description
Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.
- Conditions
- Juvenile Rheumatoid Arthritis
- Being tested
- Cholecalciferol, Calcium, Calcium and cholecalciferol, Placebo
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
2000IU Cholecalciferol P.O. Q.D.
CalciumDietary supplement
1 gm calcium as calcium carbonate
Calcium and cholecalciferolDietary supplement
2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | order of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol Receives: Dietary Supplement: Cholecalciferol; Dietary Supplement: Calcium; Dietary Supplement: Calcium and cholecalciferol; Drug: Placebo |
| Calcium | Experimental | order of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol Receives: Dietary Supplement: Cholecalciferol; Dietary Supplement: Calcium; Dietary Supplement: Calcium and cholecalciferol; Drug: Placebo |
| Cholecalciferol | Experimental | order of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium Receives: Dietary Supplement: Cholecalciferol; Dietary Supplement: Calcium; Dietary Supplement: Calcium and cholecalciferol; Drug: Placebo |
| Calcium and cholecalciferol | Experimental | order of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo Receives: Dietary Supplement: Cholecalciferol; Dietary Supplement: Calcium; Dietary Supplement: Calcium and cholecalciferol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent true calcium absorption
Measured: After 6 months of treatment
Secondary outcomes (1)
Bone Mineralization by Dual Energy x-ray absorption
Measured: After 6 months treatment plus 3 month washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startMar 1995
- Primary completionFeb 2002
- Study completionFeb 2002
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 Juvenile Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura S Hillman, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570934
- Sponsor's protocol ID
- 5387
- Status last verified
- Oct 2016
- First submitted
- 7 Dec 2007
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hillman LS, Cassidy JT, Chanetsa F, Hewett JE, Higgins BJ, Robertson JD. Percent true calcium absorption, mineral metabolism, and bone mass in children with arthritis: effect of supplementation with vitamin D3 and calcium. Arthritis Rheum. 2008 Oct;58(10):3255-63. doi: 10.1002/art.23809.
PubMed 18821668
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplementation With 2000 International Units (IU) Vitamin D, 1gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00570934
- Acronym / sponsor ID
- 5387
- Conditions
- Juvenile Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Mar 1995
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 11 Dec 2007 (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.
2000 international units (IU) vitamin D, 1 gram (gm) calcium, or both given to children with Juvenile Rheumatoid Arthritis (JRA) may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.
Detailed description
Supplementation With 2000 IU Vitamin D, 1 gm Calcium or Both on Calcium Absorption and Bone Mineralization in Children With Juvenile Rheumatoid Arthritis may increase percent true calcium absorption, bone mineral turnover and/or bone mineralization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Dietary Supplement: Cholecalciferol, Dietary Supplement: Calcium, Dietary Supplement: Calcium and cholecalciferol, Drug: Placeboorder of interventions placebo,calcium, cholecalciferol, calcium plus cholecalciferol |
| Calcium | Experimental | Dietary Supplement: Cholecalciferol, Dietary Supplement: Calcium, Dietary Supplement: Calcium and cholecalciferol, Drug: Placeboorder of treatment calcium, placebo, calcium plus cholecalciferol, cholecalciferol |
| Cholecalciferol | Experimental | Dietary Supplement: Cholecalciferol, Dietary Supplement: Calcium, Dietary Supplement: Calcium and cholecalciferol, Drug: Placeboorder of treatments cholecalciferol, calcium and Cholecalciferol, placebo, and calcium |
| Calcium and cholecalciferol | Experimental | Dietary Supplement: Cholecalciferol, Dietary Supplement: Calcium, Dietary Supplement: Calcium and cholecalciferol, Drug: Placeboorder of treatment calcium and cholecalciferol, cholecalciferol, calcium, placebo |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Juvenile Rheumatoid arthritis
Key exclusion criteria (1 listed)
- Steroid use
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 |
|---|---|---|
| Cholecalciferol2000IU Cholecalciferol P.O. Q.D. | Dietary supplement | Calcium, Calcium and cholecalciferol, Cholecalciferol, Placebo |
| Calcium1 gm calcium as calcium carbonate | Dietary supplement | Calcium, Calcium and cholecalciferol, Cholecalciferol, Placebo |
| Calcium and cholecalciferol2000IU cholecalciferol and 1 gm calcium P.O. Q.D. for 6 months | Dietary supplement | Calcium, Calcium and cholecalciferol, Cholecalciferol, Placebo |
| PlaceboPlacebo | Drug | Calcium, Calcium and cholecalciferol, Cholecalciferol, Placebo |
Primary outcome
Percent true calcium absorption
Time frame: After 6 months of treatment
1 secondary outcome
Bone Mineralization by Dual Energy x-ray absorption
Time frame: After 6 months treatment plus 3 month washout
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 10 Oct 2016.
- Derived from this study: PubMed 18821668Hillman LS, Cassidy JT, Chanetsa F, Hewett JE, Higgins BJ, Robertson JD. Percent true calcium absorption, mineral metabolism, and bone mass in children with arthritis: effect of supplementation with vitamin D3 and calcium. Arthritis Rheum. 2008 Oct;58(10):3255-63. doi: 10.1002/art.23809.
- Individual participant dataSharing planned: No
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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.
Laura S Hillman, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cholecalciferol, Calcium and Calcium and cholecalciferol in people with Juvenile Rheumatoid Arthritis, run by University of Missouri-Columbia 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 1 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 10 Oct 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percent true calcium absorption (time frame: After 6 months of treatment). 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 NCT00570934, 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 10 Oct 2016.