Molloy 2002.
Methods | Cross‐over trial of single dose secretin versus placebo |
Participants | Inclusion criteria:
Exclusion criteria: "had known chromosomal or other genetic disorders, a structural abnormality on neuroimaging, had previously received secretin, had acute or chronic pancreatic disease or a medical condition that might make participation in the study unsafe". Location/setting: Children's Hospital Medical Centre, Cincinnati, Ohio, USA Sample size: 60 Number analysed: secretin first: 19, placebo first: 23 Number of withdrawals/dropouts: 18 dropped out from original 60, although reasons for only 1 participant provided (from placebo/secretin group) ‐ they did not return for the final assessment. Gender: 37/42 analysed were male participants Mean age: 6.8 years IQ: not reported Baseline ABC‐I or other BoC: not reported Concurrent medications: not reported History of previous medications: not reported |
Interventions | Intervention (single dose secretin): a single dose of 2 IU/kg of intravenous synthetic human secretin was given at the first visit of the phase. Comparator (single dose placebo): a single dose of 2 IU/kg of placebo was given at first visit of the phase. |
Outcomes | Primary outcomes:
Secondary outcomes: none reported Timing of outcome assessments: baseline, and weeks 1, 3, 6, 9 and 12 |
Notes | Study start date: not reported Study end date: not reported Source of funding: "supported by Grant #4 T73 MC 00032‐10 awarded by the Maternal and Child Health Bureau, Health Resources and Service Administration, DHHS and by Grant #M01 RR‐08084, NIH. The human synthetic secretin used in the study was supplied by ChiRoClin (Silver Spring, MD) free of charge". Conflicts of interest: none declared Comment: author was contacted for information but no reply |