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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 September 2015 |
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Main ID: |
NCT00529841 |
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Date of registration:
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12/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia
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Scientific title:
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A Novel Therapeutic Modality for Congenital Adrenal Hyperplasia |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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7 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00529841 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Morey W Haymond, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children with salt wasting CAH otherwise healthy without other chronic disease
- Age: between 3 and 18 years of age
- Body weight 23 kg (50 lbs) or above
- Hemoglobin equal to or higher than 12 g/dl before the study
- Supportive family environment
Exclusion Criteria:
- Age less than 3 or older than 18 years at the time of study
- Other chronic disease
- Hemoglobin less than 12 g/dl
- Non-supportive family
- Allergy to local anesthetics
Criteria for study termination: If the subject's parents are unable to manage/operate the
pump, the subject will be withdrawn from the study.
Age minimum:
3 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adrenal Hyperplasia, Congenital
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Intervention(s)
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Drug: Hydrocortisone sodium acetate
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Primary Outcome(s)
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Serum 17-OHP concentration in the morning
[Time Frame: 11 days]
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Secondary Outcome(s)
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serum steroid hormone profiles
[Time Frame: 11 days]
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serum sodium
[Time Frame: study days 2,3 and 11]
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serum blood glucose
[Time Frame: study days 2,3 and 11]
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Secondary ID(s)
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GCRC # 0962
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H-19704
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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