ScoliosisPhase 3NCT01103115
Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
A Phase 3 study testing Calcium 600mg plus Vit D 400 IU and Calcium 600mg plus Vit D 800 IU in people with Scoliosis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to determine whether Calcium and Vit D supplementation is effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS). Read more about this study
- Who is it for?
- Ages 11 to 14 years, women only
- Conditions the study is for
- Scoliosis
- What is being tested?
- Calcium 600mg plus Vit D 400 IU and Calcium 600mg plus Vit D 800 IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Feb 2015
- 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 11 to 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 11-14 (Tanner stage < IV)
- Low BMD (z-score < 0 from age-matched population mean)
- Cobb's Angle greater or equal to 15°
- Presentation at the Scoliosis Clinic without prior treatment for low bone mass.
Who cannot join
- Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
- Patient with known endocrine and connective tissue abnormalities, or
- Patient with eating disorders or GI malabsorption disorders or
- Prior treatment for low bone mass before being recruited into the study.
- Patient currently taking medication that affects bone metabolism eg corticosterone or estrogen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
The purpose of this study is to determine whether Calcium and Vit D supplementation is effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).
Read the detailed description
Adolescent Idiopathic Scoliosis (AIS) is a prevalent condition mainly affecting females with disease onset at early puberty. It can lead to serious health problems and is associated with low bone mass which can persist with growth. Osteopenia is found to be an important prognostic factor for curve progression in AIS. Nutritional studies indicated AIS subjects had low dietary calcium intake. Evidences suggested that Vit D insufficiency could be present in AIS. Calcium and vitamin D supplementation can therefore be a viable treatment option for low bone mass in AIS subjects. The primary objective of this prospective randomized double-blinded placebo-controlled trial is to find out whether calcium and vitamin D supplementation can improve bone mineral density (BMD) in osteopenic AIS subjects. The secondary objective of this study is to evaluate whether the supplementation is effective in controlling curve progression in AIS.
- Conditions
- Scoliosis
- Being tested
- Calcium 600mg plus Vit D 400 IU, Calcium 600mg plus Vit D 800 IU, Placebo
- Keywords
- Adolescent Idiopathic Scoliosis, AIS, low bone mass, osteopenia, bone health, bone density
- Medical subject headings
- Scoliosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium 600mg plus Vit D 400 IUDietary supplement
Daily supplementation with 600mg Calcium plus 400IU Vitamin D3
Calcium 600mg plus Vit D 800 IUDietary supplement
Daily supplementation with 600mg Calcium plus 800IU Vitamin D3
PlaceboDietary supplement
placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects in this group will take the placebo tablets Receives: Dietary Supplement: Placebo |
| Ca600mg+VitD400IU | Active comparator | subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3 Receives: Dietary Supplement: Calcium 600mg plus Vit D 400 IU |
| Ca600mg+VitD800IU | Active comparator | subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3 Receives: Dietary Supplement: Calcium 600mg plus Vit D 800 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
To determine the effects of calcium and vitamin D intervention on improving bone mineral density of skeletally immature AIS girls with low bone mass.
Measured: 2-year time point
Secondary outcomes (1)
Curve severity
To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.
Measured: 2-year time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHENG Chun-yiu Jack, Chinese University of Hong Kong
- Investigators
- Tsz-ping Lam, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103115
- Sponsor's protocol ID
- AIS_Ca_VitD_01
- Status last verified
- Feb 2015
- First submitted
- 5 Apr 2010
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
- ClinicalTrials.gov ID
- NCT01103115
- Acronym / sponsor ID
- AIS_Ca_VitD_01
- Conditions
- Scoliosis
- Keywords
- Adolescent Idiopathic Scoliosis, AIS, low bone mass, osteopenia, bone health, bone density
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Apr 2010 (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 whether Calcium and Vit D supplementation is effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).
Detailed description
Adolescent Idiopathic Scoliosis (AIS) is a prevalent condition mainly affecting females with disease onset at early puberty. It can lead to serious health problems and is associated with low bone mass which can persist with growth. Osteopenia is found to be an important prognostic factor for curve progression in AIS. Nutritional studies indicated AIS subjects had low dietary calcium intake. Evidences suggested that Vit D insufficiency could be present in AIS. Calcium and vitamin D supplementation can therefore be a viable treatment option for low bone mass in AIS subjects. The primary objective of this prospective randomized double-blinded placebo-controlled trial is to find out whether calcium and vitamin D supplementation can improve bone mineral density (BMD) in osteopenic AIS subjects. The secondary objective of this study is to evaluate whether the supplementation is effective in controlling curve progression in AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects in this group will take the placebo tablets |
| Ca600mg+VitD400IU | Active comparator | Dietary Supplement: Calcium 600mg plus Vit D 400 IUsubjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3 |
| Ca600mg+VitD800IU | Active comparator | Dietary Supplement: Calcium 600mg plus Vit D 800 IUsubjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3 |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Between the ages of 11-14 (Tanner stage < IV)
- Low BMD (z-score < 0 from age-matched population mean)
- Cobb's Angle greater or equal to 15°
- Presentation at the Scoliosis Clinic without prior treatment for low bone mass.
Key exclusion criteria (5 listed)
- Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
- Patient with known endocrine and connective tissue abnormalities, or
- Patient with eating disorders or GI malabsorption disorders or
- Prior treatment for low bone mass before being recruited into the study.
- Patient currently taking medication that affects bone metabolism eg corticosterone or estrogen.
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 |
|---|---|---|
| Calcium 600mg plus Vit D 400 IUDaily supplementation with 600mg Calcium plus 400IU Vitamin D3 | Dietary supplement | Ca600mg+VitD400IU |
| Calcium 600mg plus Vit D 800 IUDaily supplementation with 600mg Calcium plus 800IU Vitamin D3 | Dietary supplement | Ca600mg+VitD800IU |
| Placeboplacebo tablets | Dietary supplement | Placebo |
Primary outcome
Bone mineral density
Time frame: 2-year time point
To determine the effects of calcium and vitamin D intervention on improving bone mineral density of skeletally immature AIS girls with low bone mass.
1 secondary outcome
Curve severity
Time frame: 2-year time point
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 4 Feb 2015.
- Department of Orthopaedics and Traumatology, The Chinese University of Hong KongLink provided by the sponsor.
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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.
Tsz-ping Lam principal investigator
Chinese University of Hong Kong
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 Calcium 600mg plus Vit D 400 IU and Calcium 600mg plus Vit D 800 IU in people with Scoliosis, run by Chinese University of Hong Kong at 1 site in China.
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 4 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 Feb 2015. 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 China. 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.
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?
Bone mineral density (time frame: 2-year time point). 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 4 Feb 2015.