Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia

September 10, 2015 updated by: Baylor College of Medicine

A Novel Therapeutic Modality for Congenital Adrenal Hyperplasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The adrenal gland is a small organ of the body. It produces very important chemicals called hormones. One of these hormones, cortisol (the stress hormone) helps the body fight diseases. The other hormone is the aldosterone helps to maintain the normal amount of salt and water in the body. The third type of hormones are the androgens or male hormones, which cause some of the changes during puberty, like the growth of body hair and pimples.

The salt wasting Congenital Adrenal Hyperplasia or CAH disease is a disease of the adrenal gland. Patients with this disease cannot make cortisol or the aldosterone. As a result, their body cannot fight diseases and cannot keep normal amounts of salt and water in the body. At the same time, the gland makes too much of the male hormones, which is bad for the body because too much male hormone slows down growth, increases the growth of body hair, and causes pimples and abnormal period in girls.

Patients with this disease have to take medications every day. However, the treatment does not work very well, because usually the patients do not have the right amount of hormone in their body. Usually the body gets too much hormone right after taking the pills. A couple of hours later the body has too little of the hormones, because in the meantime the body gets rid of the medication.The healthy adrenal gland makes the hormones throughout the day in different amounts. The patients with this disease take the medication only a couple of times a day. They take the Florinef tablet once a day and the Cortisol tablet two or three times a day. The treatment that we use today by mouth cannot copy the natural hormone productions of the adrenal gland. Because of this it does not make much of a difference in the patient's life.

We would like to improve the treatment and find out the effect of a new treatment. In this study we will try to imitate the body's normal hormone production and will give the medication via an insulin pump to see if this treatment method will decrease the male hormones in the blood. This study will help us to develop a new and better treatment for children and adolescents.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • BCM, Texas Children's Hospital Clinic and General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 (Hydrocortisone sodium acetate)
Subcutaneous administration of Hydrocortisone sodium acetate via insulin pump
Drug: Hydrocortisone sodium acetate
Subcutaneous administration of medication via insulin pump
Other Names:
  • Solu-Cortef injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum 17-OHP concentration in the morning
Time Frame: 11 days
11 days

Secondary Outcome Measures

Outcome Measure
Time Frame
serum steroid hormone profiles
Time Frame: 11 days
11 days
serum blood glucose
Time Frame: study days 2,3 and 11
study days 2,3 and 11
serum sodium
Time Frame: study days 2,3 and 11
study days 2,3 and 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Morey W Haymond, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 13, 2007

First Posted (ESTIMATE)

September 14, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19704
  • GCRC # 0962 (OTHER: Baylor College of Medicine)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adrenal Hyperplasia, Congenital

Clinical Trials on Hydrocortisone sodium acetate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe