Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Diseases; Scoliosis; Spinal Curvatures; Vitamin D; Bone Health
• Intervention / Treatment: Dietary supplement: Ca500mg; Dietary supplement: VitD800IU; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tsz Ping Lam; Phone Number: 35052724; Email: tplam@cuhk.edu.hk
• Study Contact Backup: Name: Echo Tsang; Phone Number: 35053309; Email: echotkl@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Orthopaedics and Traumatology, Prince of Wales Hospital
    • Contact: Tsz Ping Lam, M.B.,B.S.; Phone Number: 35052724; Email: tplam@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. girls with diagnosis of AIS confirmed after detailed clinical and radiological assessment and
2. between 10 to 14 years old and
3. Risser between 0 to 2 and
4. pre-menarche or < 1 year post-menarche and
5. Cobb angle between 10° to 20 ° and
6. no prior bracing or other treatment for scoliosis and
7. no prior treatment for bone health

Exclusion Criteria:

1. scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia or
2. patients with known endocrine and connective tissue abnormalities, or
3. patients with eating disorders or gastrointestinal malabsorption disorders or any disorders that are known to affect calcium or bone metabolism or
4. prior treatment for bone health before being recruited into the study or
5. patient currently taking medication that affects bone metabolism eg steroid or

6. patient with contra-indications for calcium and Vit-D supplementation:

   1. history of hypersensitivity to the active or placebo tablets
   2. history of renal diseases and renal calculi (nephrolithiasis)
   3. diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
   4. hypervitaminosis D

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dietary Supplement: Placebo	Other: Placebo; subjects receive placebo tablet
Active Comparator: Ca500mg + VitD800IU; Daily Supplementation with 500mg Calcium plus 800IU Vitamin D3	Dietary supplement: Ca500mg; subjects receive a daily dose of 500mg elemental calcium; Other Names: Calcium 500mg; Dietary supplement: VitD800IU; subjects receive a daily dose of 800IU VitD3; Other Names: Vitamin D3 800IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Curve progression (Cobb)	Percentage of patients with increase in Cobb angle ≥ 6 degrees	3 years
Curve progression (Bracing)	Percentage of patients who require bracing	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone health (BMD)	Improvement in areal bone mineral density measured with Dual-energy X-ray absorptiometry	3 years
Bone health (bone quality)	Improvement in bone quality measured with High-resolution peripheral quantitative computed tomography	3 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Tsz Ping Lam, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Vitamin D; Calcium; Bone Health; Adolescent Idiopathic Scoliosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Scoliosis; Spinal Diseases; Spinal Curvatures; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: CalE_Protocol_V04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No