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

The Chinese University of Hong Kong

Status and phase: Completed; Phase 3

Conditions: Scoliosis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Calcium 600mg plus Vit D 400 IU; Dietary Supplement: Calcium 600mg plus Vit D 800 IU

Study type: Interventional

Funder types: Other

Identifiers

NCT01103115

AIS_Ca_VitD_01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 330 patients

Sex: Female

Ages: 11 to 14 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects in this group will take the placebo tablets

Treatment:

Dietary Supplement: Placebo

Ca600mg+VitD400IU

Active Comparator group

Description:

subjects receive a daily dose of 600 mg elemental calcium and 400 IU vitamin D3

Treatment:

Dietary Supplement: Calcium 600mg plus Vit D 400 IU

Ca600mg+VitD800IU

Active Comparator group

Description:

subjects receive a daily dose of 600 mg elemental calcium and 800 IU vitamin D3

Treatment:

Dietary Supplement: Calcium 600mg plus Vit D 800 IU