Characteristics of studies awaiting assessment [ordered by study ID]

Bucuvalas 2001
Methods	Double-blind, placebo-controlled cross-over study (6 months of treatment followed by 6-month washout period followed by 6 months of alternative treatment)
Participants	7 pre-pubertal children aged 9.6 to 13 years of age (5 boys, 2 girls)
Interventions	IGF-1 versus placebo.
Outcomes	Primary outcome measure: linear growth rate. Secondary outcome measures: changes in BMI, body composition (DEXA scan), FEV1, blood glucose/insulin ratio.
Notes
Hardin 2001
Methods	RCT, 1 year duration. Multicentre: CF Centres at Texas Children’s Hospital, Houston and Cook’s Children’s Hospital, Forth Worth
Participants	Randomised: N = 19 (10 males, 9 females), age 8 – 13 years. Inclusion criteria diagnosed cases of CF height and weight < 10th percentile Tanner Stage 1 adequate caloric intake Exclusion criteria glucose intolerance or cystic fibrosis-related diabetes infection with B. cepacia weight loss > 3% in the 3 months prior to the study treatment with systemic or oral steroids in the prior 6 weeks poor adherence to nutritional feeding Withdrawals/losses to follow-up: n = 2, group assignment unknown
Interventions	Intervention: daily SC injection of rhGH (Nutropin AQ®) 0.3 mg/kg/week, adjusted every 3 months for weight gain. Control: no therapy. Concomitant therapy: standard GH care, antibiotics and hospitalised as needed
Outcomes	Primary outcomes pulmonary function tests nutritional parameters - height, weight, height velocity, weight velocity, lean body mass Secondary outcomes blood glucose abnormality - haemoglobin A1c, fasting and postprandial blood glucose, insulin level IGF-1 levels disease exacerbation - hospitalisation frequency and intravenous antibiotics
Notes	“Supported by a grants from Genentech Foundation and from NIH grant MO1-RR-02558 (University of Texas Clinical Research Center)”. Data could not be verified
Hardin 2005a
Methods	RCT, cross-over design (1 year of treatment and control; year 2 of both groups with treatment) Multicentre: CF Centre at Children’s Medical Center, Dallas TX; Baylor College of Medicine, Houston TX; Indiana University School of Medicine, Indianapolis IN; Washington University, St. Louis WA
Participants	Randomised: N = 18 (gender unspecified), age 8 – 13 years. Inclusion criteria diagnosed cases of CF height and weight < 10th percentile Tanner Stage 1 compliant with nutritional therapy Exclusion criteria treatment with systemic corticosteroid therapy in past 6 weeks colonisation with B. cepacia Withdrawal or loss to follow-up: none reported.
Interventions	Intervention: daily SC injection of rhGH (Nutropin AQ®) 0.3mg/kg/week; dose adjusted every 3 months for weight gain Control: no treatment. Concomitant treatment: pancreatic enzyme treatment. 9 participants received rhGH treatment in the first year and 9 received no treatment. All received treatment with rhGH in the 2nd year of study
Outcomes	Primary outcomes pulmonary function tests (FEV1, FVC) nutritional parameters - height, weight, height velocity, weight velocity, lean body mass Secondary outcomes blood glucose abnormality - casual blood glucose (but no comparison with controls) IGF-1 levels changes in disease exacerbation - hospitalisation, outpatient antibiotic use
Notes	Data from the 1st year of treatment could be used in the review, once data verified. Bone mineral content is additional outcome of interest reported in this study but not in the review “Supported in part by the Genetech Center for Clinical Research.”
Hardin 2005b
Methods	Quasi-randomised study. Control data for BMC was derived from age, gender and ethnicity matched healthy children, but participants with CF randomised into treatment and non-treatment groups
Participants	Randomised: N = 32, (17 males, 15 females), age 7–12 years. Inclusion criteria stable CF, not on systemic steroids height <10th percentile, weight < 90% of the 50th percentile bone age 9.6 – 9.9 years Exclusion criteria: not specified in the manuscript. Withdrawals or loss to follow-up: none reported.
Interventions	Intervention: daily SC injections rhGH (Nutropin AQ®) 0.3 mg/kg/week. Control: no treatment. 32 participants of which 16 were randomly assigned to receive treatment for 1 year. It appears that control data from normal children was used for bone mineral content comparison only. Anthropometric data appears to be compared in the treatment and non-treatment group of the selected 32 CF children
Outcomes	Primary outcomes nutritional parameters - height, weight, lean body mass Secondary outcomes IGF-1 level
Notes	Bone mineral content is outcome of importance reported in this study, but not in our review Study supported by: NIH:1 K08 DK02365-01 and MO1-RR-02558, a grant from the National Cystic Fibrosis Foundation, a grant from Genentech Center for Research and the US Department of Agriculture Agreement 58-6250-1-003
Hardin 2006
Methods	RCT of cross-over design (2 periods of 1 year each). Multicentre: 10 geographically dispersed centres in United States of America
Participants	Randomised: N = 61 (32 males, 29 females). Inclusion criteria age 7 – 12 years diagnosed CF height and weight < 25th percent Tanner Stage 1 Exclusion criteria pre-existing diabetes systemic corticosteroid use within 6 months colonisation with B. cepacia addition of oral, enteral or parenteral supplementation within the past year Withdrawals or loss to follow-up: 4 (2 from treatment and 2 from control group)
Interventions	Intervention: daily SC injections of rhGH (Nutropin AQ®) 0.3 mg/kg/week. Control: no treatment. Concomittant treatment permitted pancreatic enzyme replacement vitamin supplementation inhaled bronchodilators and mucolytic clinically indicated antibiotics Participant groups were crossed over after 1 year of treatment
Outcomes	Primary outcomes pulmonary function tests - change in FVC, change in FEV1 nutritional parameters - height, weight, height velocity, weight velocity, lean body mass QoL - Health-Related QoL Questionnaire (HRQoL) Secondary outcomes blood glucose abnormality - random blood glucose measurement change in disease exacerbation - hospitalisation frequency and need for antibiotics
Notes	Data from year 1 may be included in the review after verification of data Bone mineral content reported as an additional outcome of significance, not in this review
Schnabel 1997
Methods	6-month study, cross-over design, not clear if randomised. Single centre
Participants	12 participants with CF (3 female, 9 male), mean (SD) age 12.2 (2.3) years
Interventions	GH therapy (0.11 – 0.14 IU/kg/day) compared to high calorie diet
Outcomes	Lean tissue mass, fat mass, weight.
Notes	Await full translation and further details from authors.

B. cepacia: Burkholderia cepacia

BMC: bone mineral content

BMI: body mass index

CF: cystic fibrosis

FEV₁: forced expiratory volume in one second

FVC: forced vital capacity

GH: growth hormone

IU: international units

QoL: quality of life

RCT: randomised controlled trial

rhGH: recombinant human growth hormone

SD: standard deviation

SC: subcutaneous