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A Prospective Randomized Study

Winston W. K. Koo, MBBS; Reginald C. Tsang, MBBS; James W. Poser, PhD; Peter Laskarzewski, PhD; Donna Buckley; Robert Johnson, PhD; Jean J. Steichen, MD

Am J Dis Child. 1986;140(11):1152-1158.

Abstract
• The hypothesis of this study was that pharmacologic doses of calcitriol (1,25-dihydroxyvitamin D₃) would result in elevated levels of serum osteocalcin, the major noncollagenous bone protein, and calcium in infants of very low birth weight (<1500 g). Twenty-four infants of very low birth weight but of the appropriate weight for gestational age were matched in 250-g weight ranges and randomized into calcitriol treatment and control groups on the first day after birth. Treated infants received 4 µg/kg of calcitriol intravenously on entry and on the second and third study days. Controls did not receive calcitriol. Four infants from each group were hypocalcemic (serum calcium level, <7.0 mg/dL [<1.75 mmol/L]) on entry (five to 20 hours after birth) to the study. Seven infants received calcium replacement; data analyses with and without these infants were similar. Of the remaining 17 infants, eight were in the treatment group and nine were in the control group. Calcitriol significantly increased serum calcium and osteocalcin concentrations on days 2, 3, and 4 after birth compared with the control group. None of eight treated infants manifested hypocalcemia after calcitriol vs eight of nine controls. There were no acute changes in heart rate, respiratory rate, systolic blood pressure, or urinary calcium loss nor were there changes at the infusion site, but the diastolic blood pressure increased with treatment. Although high doses of calcitriol may elevate serum calcium concentrations in infants of very low birth weight, we suggest that the long-term or subtle biologic effects of high doses of calcitriol remain to be studied and that its routine use not be recommended at present.

(AJDC 1986;140:1152-1158)

Author Affiliations
From the Division of Neonatology, Department of Pediatrics (Drs Koo, Tsang, and Steichen and Ms Buckley), and the Section of Clinical Research Management, Department of Medicine (Dr Laskarzewski), University of Cincinnati Medical Center, Children's Hospital Medical Center; Procter & Gamble Co, Cincinnati (Dr Poser); and Good Samaritan Hospital, Cincinnati (Dr Johnson). Dr Koo is now with the University of Alberta, Neonatology Division, Edmonton.

Footnotes
Accepted for publication June 23, 1986.

Reprint requests to University of Alberta, Neonatology Division, 2C300 Walter Mackenzie Health Centre, Edmonton, Alberta, Canada T6G 2R7 (Dr Koo).

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