NCT00529841

Brief Summary

The purpose of this study is to develop a more physiological approach to the management of children and adolescents with salt wasting Congenital Adrenal Hyperplasia. We will administer the glucocorticosteroid via insulin infusion pump to see whether this treatment will improve the serum hormone concentrations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.7 years

First QC Date

September 12, 2007

Last Update Submit

September 10, 2015

Conditions

Adrenal Hyperplasia, Congenital

Keywords

Salt Wasting Congenital Adrenal HyperplasiaSubcutaneous Hydrocortisone

Outcome Measures

Primary Outcomes (1)

  • Serum 17-OHP concentration in the morning

    11 days

Secondary Outcomes (3)

  • serum steroid hormone profiles

    11 days

  • serum blood glucose

    study days 2,3 and 11

  • serum sodium

    study days 2,3 and 11

Study Arms (1)

1 (Hydrocortisone sodium acetate)

EXPERIMENTAL

Subcutaneous administration of Hydrocortisone sodium acetate via insulin pump

Drug: Hydrocortisone sodium acetate

Interventions

Hydrocortisone sodium acetateDRUG

Subcutaneous administration of medication via insulin pump

Also known as: Solu-Cortef injection
1 (Hydrocortisone sodium acetate)

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BCM, Texas Children's Hospital Clinic and General Clinical Research Center

Houston, Texas, 77030, United States

Location

Related Publications (12)

  • Esteban NV, Loughlin T, Yergey AL, Zawadzki JK, Booth JD, Winterer JC, Loriaux DL. Daily cortisol production rate in man determined by stable isotope dilution/mass spectrometry. J Clin Endocrinol Metab. 1991 Jan;72(1):39-45. doi: 10.1210/jcem-72-1-39.

    PMID: 1986026BACKGROUND

  • Kerrigan JR, Veldhuis JD, Leyo SA, Iranmanesh A, Rogol AD. Estimation of daily cortisol production and clearance rates in normal pubertal males by deconvolution analysis. J Clin Endocrinol Metab. 1993 Jun;76(6):1505-10. doi: 10.1210/jcem.76.6.8501158.

    PMID: 8501158BACKGROUND

  • Speiser PW. Toward better treatment of congenital adrenal hyperplasia. Clin Endocrinol (Oxf). 1999 Sep;51(3):273-4. doi: 10.1046/j.1365-2265.1999.00780.x. No abstract available.

    PMID: 10469004BACKGROUND

  • Cutler GB Jr, Laue L. Congenital adrenal hyperplasia due to 21-hydroxylase deficiency. N Engl J Med. 1990 Dec 27;323(26):1806-13. doi: 10.1056/NEJM199012273232605. No abstract available.

    PMID: 2247119BACKGROUND

  • Winterer J, Chrousos GP, Loriaux DL, Cutler GB Jr. Effect of hydrocortisone dose schedule on adrenal steroid secretion in congenital adrenal hyperplasia. J Pediatr. 1985 Jan;106(1):137-42. doi: 10.1016/s0022-3476(85)80486-8.

    PMID: 3871229BACKGROUND

  • Wallace WH, Crowne EC, Shalet SM, Moore C, Gibson S, Littley MD, White A. Episodic ACTH and cortisol secretion in normal children. Clin Endocrinol (Oxf). 1991 Mar;34(3):215-21. doi: 10.1111/j.1365-2265.1991.tb00297.x.

    PMID: 1645237BACKGROUND

  • Merza Z, Rostami-Hodjegan A, Memmott A, Doane A, Ibbotson V, Newell-Price J, Tucker GT, Ross RJ. Circadian hydrocortisone infusions in patients with adrenal insufficiency and congenital adrenal hyperplasia. Clin Endocrinol (Oxf). 2006 Jul;65(1):45-50. doi: 10.1111/j.1365-2265.2006.02544.x.

    PMID: 16817818BACKGROUND

  • Lukert BP. Editorial: glucocorticoid replacement--how much is enough? J Clin Endocrinol Metab. 2006 Mar;91(3):793-4. doi: 10.1210/jc.2005-2737. No abstract available.

    PMID: 16522704BACKGROUND

  • Claude J.Migeon. Can the Long Range Results of the Treatment of Congenital Adrenal Hyperplasia be improved? JCEM 1996 Vol 81, No 9 3187-3189

    BACKGROUND

  • Laue L, Merke DP, Jones JV, Barnes KM, Hill S, Cutler GB Jr. A preliminary study of flutamide, testolactone, and reduced hydrocortisone dose in the treatment of congenital adrenal hyperplasia. J Clin Endocrinol Metab. 1996 Oct;81(10):3535-9. doi: 10.1210/jcem.81.10.8855797.

    PMID: 8855797BACKGROUND

  • Mah PM, Jenkins RC, Rostami-Hodjegan A, Newell-Price J, Doane A, Ibbotson V, Tucker GT, Ross RJ. Weight-related dosing, timing and monitoring hydrocortisone replacement therapy in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2004 Sep;61(3):367-75. doi: 10.1111/j.1365-2265.2004.02106.x.

    PMID: 15355454BACKGROUND

  • Sheila K.Gunn et al Subcutaneous Hydrocortisone Delivery mimics Physiologic Cortisol Concentrations, Poster, Endocrine Society Meeting 2000

    BACKGROUND

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Interventions

hydrocortisone hemisuccinate

Condition Hierarchy (Ancestors)

Adrenogenital SyndromeDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSteroid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAdrenal Gland DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Morey W Haymond, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

January 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

US(1)