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Trial record 18 of 370 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Diseases"

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

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ClinicalTrials.gov Identifier: NCT03533010
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tsz-ping Lam, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Scoliosis Spinal Curvatures Spinal Diseases Bone Health Vitamin D Dietary Supplement: Ca500mg Dietary Supplement: VitD800IU Other: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Calcium 500mg

Dietary Supplement: VitD800IU
subjects receive a daily dose of 800IU VitD3
Other Name: Vitamin D3 800IU

Placebo Comparator: Placebo
Dietary Supplement: Placebo
Other: Placebo
subjects receive placebo tablet




Primary Outcome Measures :
  1. Curve progression (Cobb) [ Time Frame: 3 years ]
    Percentage of patients with increase in Cobb angle ≥ 6 degrees

  2. Curve progression (Bracing) [ Time Frame: 3 years ]
    Percentage of patients who require bracing


Secondary Outcome Measures :
  1. Bone health (BMD) [ Time Frame: 3 years ]
    Improvement in areal bone mineral density measured with Dual-energy X-ray absorptiometry

  2. Bone health (bone quality) [ Time Frame: 3 years ]
    Improvement in bone quality measured with High-resolution peripheral quantitative computed tomography



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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533010


Contacts
Contact: Tsz Ping Lam 35052724 tplam@cuhk.edu.hk
Contact: Echo Tsang 35053309 echotkl@cuhk.edu.hk

Locations
Hong Kong
Department of Orthopaedics and Traumatology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Tsz Ping Lam, M.B.,B.S.    35052724    tplam@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Tsz Ping Lam Chinese University of Hong Kong

Responsible Party: Tsz-ping Lam, Associate Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03533010     History of Changes
Other Study ID Numbers: CalE_Protocol_V04
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tsz-ping Lam, Chinese University of Hong Kong:
Adolescent Idiopathic Scoliosis
Bone Health
Treatment
Vitamin D
Calcium

Additional relevant MeSH terms:
Spinal Diseases
Scoliosis
Spinal Curvatures
Bone Diseases
Musculoskeletal Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents