Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation
Primary Purpose
Scoliosis, Spinal Curvatures, Spinal Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Ca500mg
VitD800IU
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, Bone Health, Treatment, Vitamin D, Calcium
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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:
- 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
Sites / Locations
- Department of Orthopaedics and Traumatology, Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ca500mg + VitD800IU
Placebo
Arm Description
Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3
Dietary Supplement: Placebo
Outcomes
Primary Outcome Measures
Curve progression (Cobb)
Percentage of patients with increase in Cobb angle ≥ 6 degrees
Curve progression (Bracing)
Percentage of patients who require bracing
Secondary Outcome Measures
Bone health (BMD)
Improvement in areal bone mineral density measured with Dual-energy X-ray absorptiometry
Bone health (bone quality)
Improvement in bone quality measured with High-resolution peripheral quantitative computed tomography
Full Information
NCT ID
NCT03533010
First Posted
April 30, 2018
Last Updated
March 21, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03533010
Brief Title
Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Spinal Curvatures, Spinal Diseases, Bone Health, Vitamin D
Keywords
Adolescent Idiopathic Scoliosis, Bone Health, Treatment, Vitamin D, Calcium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ca500mg + VitD800IU
Arm Type
Active Comparator
Arm Description
Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dietary Supplement: Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Ca500mg
Other Intervention Name(s)
Calcium 500mg
Intervention Description
subjects receive a daily dose of 500mg elemental calcium
Intervention Type
Dietary Supplement
Intervention Name(s)
VitD800IU
Other Intervention Name(s)
Vitamin D3 800IU
Intervention Description
subjects receive a daily dose of 800IU VitD3
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
subjects receive placebo tablet
Primary Outcome Measure Information:
Title
Curve progression (Cobb)
Description
Percentage of patients with increase in Cobb angle ≥ 6 degrees
Time Frame
3 years
Title
Curve progression (Bracing)
Description
Percentage of patients who require bracing
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Bone health (BMD)
Description
Improvement in areal bone mineral density measured with Dual-energy X-ray absorptiometry
Time Frame
3 years
Title
Bone health (bone quality)
Description
Improvement in bone quality measured with High-resolution peripheral quantitative computed tomography
Time Frame
3 years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tsz Ping Lam
Phone
35052724
Email
tplam@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Echo Tsang
Phone
35053309
Email
echotkl@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsz Ping Lam
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsz Ping Lam, M.B.,B.S.
Phone
35052724
Email
tplam@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation
We'll reach out to this number within 24 hrs