Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 330
- Locations
- 1
- Primary Endpoint
- Bone mineral density
Study Overview
Brief 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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 14 Years (Child)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Curve severity(2-year time point)
Investigators
CHENG Chun-yiu Jack
Professor
Chinese University of Hong Kong