Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)

Can Calcium and Vitamin D Supplementation Improve Bone Mineral Density and Curve Progression in Girls With Adolescent Idiopathic Scoliosis?

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103115

Enrollment

330

Registered

2010-04-14

Start date

2010-04-30

Completion date

2015-02-28

Last updated

2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scoliosis

Keywords

Adolescent Idiopathic Scoliosis, AIS, low bone mass, osteopenia, bone health, bone density

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.

Interventions

DIETARY_SUPPLEMENTCalcium 600mg plus Vit D 400 IU

Daily supplementation with 600mg Calcium plus 400IU Vitamin D3

DIETARY_SUPPLEMENTCalcium 600mg plus Vit D 800 IU

Daily supplementation with 600mg Calcium plus 800IU Vitamin D3

DIETARY_SUPPLEMENTPlacebo

placebo tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

11 Years to 14 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Bone mineral density	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

Measure	Time frame	Description
Curve severity	2-year time point	To determine the effects of calcium and vitamin D intervention on preventing curve progression of skeletally immature AIS girls with low bone mass.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026