NCT00001195

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\>

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,247

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1984

Longer than P75 for all trials

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

August 28, 1984

Completed
15.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
15 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2014

Completed
Last Updated

October 6, 2017

Status Verified

October 20, 2014

First QC Date

November 3, 1999

Last Update Submit

October 5, 2017

Conditions

Healthy

Keywords

DevelopmentHormonesGrowthMetabolismEating BehaviorBody CompositionNormal Volunteer

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Good general health.
  • Age 2 to 18 years.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

  • Nisula BC, Loriaux DL, Wilson YA. Solid phase method for measurement of the binding capacity of testosterone-estradiol binding globulin in human serum. Steroids. 1978 May;31(5):681-90. doi: 10.1016/s0039-128x(78)80008-7. No abstract available.

    PMID: 566971BACKGROUND

  • Nisula BC, Dunn JF. Measurement of the testosterone binding parameters for both testosterone-estradiol binding globulin and albumin in individual serum samples. Steroids. 1979 Dec;34(7):771-91. doi: 10.1016/0039-128x(79)90090-4.

    PMID: 575443BACKGROUND

  • Wehmann RE, Rubenstein HA, Nisula BC. A sensitive, convenient radioimmunoassay procedure which demonstrates that serum hTSH is suppressed below the normal range in thyrotoxic patients. Endocr Res Commun. 1979;6(3):249-55. doi: 10.3109/07435807909061799.

    PMID: 520279BACKGROUND

  • Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496.

    PMID: 29718281DERIVED

  • Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18.

    PMID: 26210388DERIVED

  • Tanofsky-Kraff M, Shomaker LB, Stern EA, Miller R, Sebring N, Dellavalle D, Yanovski SZ, Hubbard VS, Yanovski JA. Children's binge eating and development of metabolic syndrome. Int J Obes (Lond). 2012 Jul;36(7):956-62. doi: 10.1038/ijo.2011.259. Epub 2012 Jan 10.

    PMID: 22234282DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Jack A Yanovski, M.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 28, 1984

Study Completion

October 20, 2014

Last Updated

October 6, 2017

Record last verified: 2014-10-20

Locations

US(1)