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Endocrine Studies of Healthy Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001195
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : October 6, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

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. <TAB>

Condition or disease

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 1247 participants
Official Title: Endocrine Studies of Healthy Children
Study Start Date : August 28, 1984
Study Completion Date : October 20, 2014

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Good general health.

Age 2 to 18 years.


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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001195

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Jack A Yanovski, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00001195    
Other Study ID Numbers: 840169
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 20, 2014
Keywords provided by National Institutes of Health Clinical Center (CC):
Eating Behavior
Body Composition
Normal Volunteer