The purpose of this study is to determine whether calcium and vitamin D supplementation, over a nine-month period, optimizes bone mineralization in boys with risperidone-induced hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the supplementation group will have higher bone mineral density compared to those in the placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
47
Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
The University of Iowa
Iowa City, Iowa, United States
Trabecular Bone Mineral Density in the Ultradistal Radius
Peripheral quantitative computed tomography (pQCT) scan was obtained at the 4% and 20% sites of the nondominant radius to estimate trabecular and cortical BMD, respectively. A Stratec XCT-2000 scanner, software version 6.0 (Stratec, Inc., Pforzheim, Germany),was used. Trabecular BMD was measured as the mean density of the 85% central area of the bone's cross-section. Outcomes were measured at baseline, 18 weeks, and 36 weeks later.
Time frame: 36 weeks
Total Body Bone Mineral Content
Outcomes were measured at baseline, 18 weeks, and 36 weeks later.
Time frame: 36 weeks
Bone Strength Index, mg2/mm4
Measured at the 4% radius site.
Time frame: 36 weeks
Cortical Bone Mineral Density
This was measured at the 20% radius site.
Time frame: 36 weeks
Cortical Thickness
This was measured at the 20% radius site.
Time frame: 36 weeks
Periosteal Circumference
This was measured at the 20% radius site.
Time frame: 36 weeks
Endosteal Circumference
This was measured at the 20% radius site.
Time frame: 36 weeks
Polar Section Modulus
This was measured at the 20% radius site.
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Time frame: 36 weeks