Clinical Trials Directory

Trials / Completed

CompletedNCT00001195

Endocrine Studies of Healthy Children

Status
Completed
Phase
Study type
Observational
Enrollment
1,247 (actual)
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
Sex
All
Age
2 Years – 18 Years
Healthy volunteers
Not accepted

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\>

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.

Conditions

Timeline

Start date
1984-08-28
Completion
2014-10-20
First posted
1999-11-04
Last updated
2017-10-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00001195. Inclusion in this directory is not an endorsement.