Endocrine Studies of Healthy Children



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:2 - 18
Updated:10/8/2017
Start Date:August 28, 1984
End Date:October 20, 2014

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Researchers would like to determine normal ranges for hormone levels and to learn more about
the genetics involved in hormone production and action. Researchers will take samples of
blood, urine, saliva, and stool from healthy children ages 5-17 in order to study different
aspects of hormones.

Establishing a range of normal hormone levels in children will make diagnosing illnesses with
abnormal levels of hormones much easier. Hormone levels in the body can change throughout the
day. By collecting samples at different times researchers hope to learn more about the normal
daytime and nighttime patterns of hormone secretion. Because some hormone levels change with
body size, researchers will also take measurements of patient's body composition.

This study will involve children and observe them as inpatients or as outpatients.

We wish to obtain blood, urine, saliva, and stool specimens from healthy children ages 2-18
years for use in establishing the normal ranges of levels of hormones and the variations in
genes that are important for hormones to act. Such hormone values are extremely important to
allow endocrinologists to determine when hormone levels are truly abnormal in children
suspected of an illness. Because the values of some hormones change with body size, we will
obtain measurements of body composition when studying such hormones. Children participating
in this study may be studied in the outpatient clinic (at most 2 blood draws) or as
inpatients on the pediatric ward (for frequent blood sampling using an intravenous line over
a 24-hour period). Other studies that may be performed as part of this study include
ultrasound examinations of the thyroid, adrenal, ovaries or testes, and x-ray of the hand and
wrist for bone age determination.

- INCLUSION CRITERIA:

Good general health.

Age 2 to 18 years.

EXCLUSION CRITERIA:

Volunteers will be excluded for the following reasons:

Presence of renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing's
syndrome) or pulmonary disorders (other than asthma not requiring continuous medication);

Individuals who have, or whose parent or guardians have, current substance abuse or a
psychiatric disorder or other condition which, in the opinion of the investigators, would
impede the ability to give informed consent or possibly hinder completion of the study;

Subjects who regularly use prescription medications are not eligible. The use of
over-the-counter medications will be reviewed on a case-by-case basis;

For those sub-studies involving MRI, inability to undergo MRI (e.g., volunteers with metal
within their bodies including cardiac pacemakers, neural pacemakers, aneurysmal clips,
shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or
electromechanical devices such as infusion pumps, nerve stimulators, bone growth
stimulators, etc. that are contraindications).
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
?
mi
from
Bethesda, MD
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