BACKGROUND:Growth failure frequently complicates Crohn's disease in childhood. Abnormalities in the growth hormone (GH)/insulin-like growth factor-1 axis may occur. The effects of administered GH on growth have not been studied previously in a randomized trial. METHODS:Seven children (6 boys and 1 girl; age, 11.9-16 yr) with Crohn's disease and growth failure were enrolled. In phase 1, patients were randomized to either GH (0.05 mg/kg per day) or placebo; in phase 2, patients who received placebo during the first year received GH for various time periods. Follow-up was every 3 months for up to 2 years. RESULTS: During placebo treatment (4 patients), mean height-for-age z score (haz) increased 0.23 in the first half year and 0.55 in the second half year. The mean improvement in haz during the first half year of GH treatment (7 patients) was 0.13; during the second half year (5 patients), haz decreased 0.01. Effects of GH varied among patients; 2 patients grew only when nutritional supplementation was added. Observed changes were not statistically significant; however, the number of patients studied was small, and statistical analyses could have been affected by sample size. Serum insulin-like growth factor-1 levels correlated with height velocity. Only 2 patients later reached expected adult height. CONCLUSIONS: In this pilot study, GH treatment at the dose given did not stimulate growth in children with Crohn's disease and short stature. Whether or not GH plus nutritional therapy would be effective in promoting sustained catch-up growth remains to be determined.
RCT Entities:
BACKGROUND:Growth failure frequently complicates Crohn's disease in childhood. Abnormalities in the growth hormone (GH)/insulin-like growth factor-1 axis may occur. The effects of administered GH on growth have not been studied previously in a randomized trial. METHODS: Seven children (6 boys and 1 girl; age, 11.9-16 yr) with Crohn's disease and growth failure were enrolled. In phase 1, patients were randomized to either GH (0.05 mg/kg per day) or placebo; in phase 2, patients who received placebo during the first year received GH for various time periods. Follow-up was every 3 months for up to 2 years. RESULTS: During placebo treatment (4 patients), mean height-for-age z score (haz) increased 0.23 in the first half year and 0.55 in the second half year. The mean improvement in haz during the first half year of GH treatment (7 patients) was 0.13; during the second half year (5 patients), haz decreased 0.01. Effects of GH varied among patients; 2 patients grew only when nutritional supplementation was added. Observed changes were not statistically significant; however, the number of patients studied was small, and statistical analyses could have been affected by sample size. Serum insulin-like growth factor-1 levels correlated with height velocity. Only 2 patients later reached expected adult height. CONCLUSIONS: In this pilot study, GH treatment at the dose given did not stimulate growth in children with Crohn's disease and short stature. Whether or not GH plus nutritional therapy would be effective in promoting sustained catch-up growth remains to be determined.
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Authors: Mabrouka A Altowati; Ashley P Jones; Helen Hickey; Paula R Williamson; Farah M Barakat; Nicolene C Plaatjies; Ben Hardwick; Richard K Russell; Thomas Jaki; S Faisal Ahmed; Ian R Sanderson Journal: Pilot Feasibility Stud Date: 2016-12-05