ScoliosisNCT03533010
Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation
A study testing Ca500mg and VitD800IU in people with Scoliosis and Spinal Curvatures, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded… Read more about this study
- Who is it for?
- Ages 10 to 14 years, women only
- Conditions the study is for
- Scoliosis, Spinal Curvatures, Spinal Diseases
- What is being tested?
- Ca500mg and VitD800IU
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2018to 30 Dec 2023
- 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 10 to 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- girls with diagnosis of AIS confirmed after detailed clinical and radiological assessment and
- between 10 to 14 years old and
- Risser between 0 to 2 and
- pre-menarche or < 1 year post-menarche and
- Cobb angle between 10° to 20 ° and
- no prior bracing or other treatment for scoliosis and
- no prior treatment for bone health
Who cannot join
- scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia or
- patients with known endocrine and connective tissue abnormalities, or
- patients with eating disorders or gastrointestinal malabsorption disorders or any disorders that are known to affect calcium or bone metabolism or
- prior treatment for bone health before being recruited into the study or
- patient currently taking medication that affects bone metabolism eg steroid or
- patient with contra-indications for calcium and Vit-D supplementation:
Show all 10Show fewer
- history of hypersensitivity to the active or placebo tablets
- history of renal diseases and renal calculi (nephrolithiasis)
- diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
- hypervitaminosis D
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Orthopaedics and Traumatology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Preventing Curve Progression and the Need for Bracing in Early Diagnosed Adolescent Idiopathic Scoliosis Using Calcium Plus Vitamin D Supplementation - A Randomized Double-blinded Placebo-controlled Trial
There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression in AIS. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology(HR-pQCT) to assess bone health will also be evaluated.
Read the detailed description
This study investigates if calcium (Ca) plus Vitamin D (Vit-D) supplementation can prevent curve progression and improve bone health in early Adolescent Idiopathic Scoliosis (AIS) during pubertal growth.
AIS is a prevalent three-dimensional spinal deformity mainly affecting girls at puberty. It can lead to serious complications including spine degeneration, cardiopulmonary compromise, grossly deformed torso and psychosocial disorders. Current treatments are far from being satisfactory, with bracing being lengthy and physically demanding and surgery being a major invasive procedure.
There is an association between AIS and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology (HR-pQCT) to assess bone health will also be evaluated.
- Conditions
- Scoliosis, Spinal Curvatures, Spinal Diseases, Bone Health, Vitamin D
- Being tested
- Ca500mg, VitD800IU, Placebo
- Keywords
- Adolescent Idiopathic Scoliosis, Bone Health, Treatment, Vitamin D, Calcium
- Medical subject headings
- Scoliosis, Spinal Curvatures, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ca500mgDietary supplement
Also called Calcium 500mg
subjects receive a daily dose of 500mg elemental calcium
VitD800IUDietary supplement
Also called Vitamin D3 800IU
subjects receive a daily dose of 800IU VitD3
PlaceboOther
subjects receive placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Ca500mg + VitD800IU | Active comparator | Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3 Receives: Dietary Supplement: Ca500mg; Dietary Supplement: VitD800IU |
| Placebo | Placebo comparator | Dietary Supplement: Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curve progression (Cobb)
Percentage of patients with increase in Cobb angle ≥ 6 degrees
Measured: 3 years
Curve progression (Bracing)
Percentage of patients who require bracing
Measured: 3 years
Secondary outcomes (2)
Bone health (BMD)
Improvement in areal bone mineral density measured with Dual-energy X-ray absorptiometry
Measured: 3 years
Bone health (bone quality)
Improvement in bone quality measured with High-resolution peripheral quantitative computed tomography
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Jun 2018
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsz-ping Lam, Chinese University of Hong Kong
- Investigators
- Tsz Ping Lam, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533010
- Sponsor's protocol ID
- CalE_Protocol_V04
- Status last verified
- Dec 2024
- First submitted
- 30 Apr 2018
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Curve Progression and the Need for Bracing in Early Diagnosed Adolescent Idiopathic Scoliosis Using Calcium Plus Vitamin D Supplementation - A Randomized Double-blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03533010
- Acronym / sponsor ID
- CalE_Protocol_V04
- Conditions
- Scoliosis, Spinal Curvatures, Spinal Diseases, Bone Health, Vitamin D
- Keywords
- Adolescent Idiopathic Scoliosis, Bone Health, Treatment, Vitamin D, Calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 22 May 2018 (actual)
- 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.
There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression in AIS. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology(HR-pQCT) to assess bone health will also be evaluated.
Detailed description
This study investigates if calcium (Ca) plus Vitamin D (Vit-D) supplementation can prevent curve progression and improve bone health in early Adolescent Idiopathic Scoliosis (AIS) during pubertal growth.
AIS is a prevalent three-dimensional spinal deformity mainly affecting girls at puberty. It can lead to serious complications including spine degeneration, cardiopulmonary compromise, grossly deformed torso and psychosocial disorders. Current treatments are far from being satisfactory, with bracing being lengthy and physically demanding and surgery being a major invasive procedure.
There is an association between AIS and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angle≥6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology (HR-pQCT) to assess bone health will also be evaluated.
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 |
|---|---|---|
| Ca500mg + VitD800IU | Active comparator | Dietary Supplement: Ca500mg, Dietary Supplement: VitD800IUDaily Supplementation with 500mg Calcium plus 800IU Vitamin D3 |
| Placebo | Placebo comparator | Other: PlaceboDietary Supplement: Placebo |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- girls with diagnosis of AIS confirmed after detailed clinical and radiological assessment and
- between 10 to 14 years old and
- Risser between 0 to 2 and
- pre-menarche or < 1 year post-menarche and
- Cobb angle between 10° to 20 ° and
Key exclusion criteria (10 listed)
- scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia or
- patients with known endocrine and connective tissue abnormalities, or
- patients with eating disorders or gastrointestinal malabsorption disorders or any disorders that are known to affect calcium or bone metabolism or
- prior treatment for bone health before being recruited into the study or
- patient currently taking medication that affects bone metabolism eg steroid or
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 |
|---|---|---|
| Ca500mgAlso: Calcium 500mgsubjects receive a daily dose of 500mg elemental calcium | Dietary supplement | Ca500mg + VitD800IU |
| VitD800IUAlso: Vitamin D3 800IUsubjects receive a daily dose of 800IU VitD3 | Dietary supplement | Ca500mg + VitD800IU |
| Placebosubjects receive placebo tablet | Other | Placebo |
Primary outcome
Curve progression (Cobb)
Time frame: 3 years
Percentage of patients with increase in Cobb angle ≥ 6 degrees
Curve progression (Bracing)
Time frame: 3 years
Percentage of patients who require bracing
2 secondary outcomes
Bone health (BMD)
Time frame: 3 years
Bone health (bone quality)
Time frame: 3 years
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 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
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Detecting and Monitoring Scoliosis Without Radiography: Standard Radiographic Monitoring Program Versus Self-Screening With Momentum SpineTM
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Active, not recruiting
Enhancing the Therapeutic Effect of Bracing for Adolescent Idiopathic Scoliosis With a Hybrid Bracing Protocol
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Scoliosis Treatment: Evaluating Patient Suitability
Degenerative Scoliosis
RecruitingObservational study
Quality of Life (HRQoL) of AIS Patients Who Require Bracing or Surgery Using SRS-22 Questionnaire
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Effectiveness of a Horse Riding Simulator in Adolescents With Idiopathic Scoliosis
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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 study testing Ca500mg and VitD800IU in people with Scoliosis and Spinal Curvatures, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 10 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 Dec 2024. 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 Hong Kong. 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 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?
Curve progression (Cobb) (time frame: 3 years). 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?
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 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.