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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004365
Other study ID # 199/11940
Secondary ID NU-571
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date September 1995
Est. completion date February 2000

Study information

Verified date December 2003
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES: I. Assess pituitary size and anatomic configuration by magnetic resonance imaging (MRI) in 4 affected dwarfs in the province of Sindh, Pakistan.

II. Evaluate ultradian growth hormone (GH) secretory patterns in 4 affected dwarfs.


Description:

PROTOCOL OUTLINE: Pituitary size and anatomy and growth hormone response are evaluated.

All patients undergo MRI of the pituitary fossa on day 1. On day 2, homozygous patients receive a slow infusion of normal saline with blood sampling every 10 minutes.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date February 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 60 Years
Eligibility - Familial Dwarfism of Sindh

- Severe short stature but proportionate without dysmorphic features

- Normal body size and weight at birth

- Bone age is severely delayed

- Puberty is somewhat delayed (age 15-16)

- Fertility present in at least 3 dwarfs

Study Design

Primary Purpose: Screening


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Northwestern University

References & Publications (2)

Baumann G, Maheshwari H. The Dwarfs of Sindh: severe growth hormone (GH) deficiency caused by a mutation in the GH-releasing hormone receptor gene. Acta Paediatr Suppl. 1997 Nov;423:33-8. — View Citation

Maheshwari HG, Silverman BL, Dupuis J, Baumann G. Phenotype and genetic analysis of a syndrome caused by an inactivating mutation in the growth hormone-releasing hormone receptor: Dwarfism of Sindh. J Clin Endocrinol Metab. 1998 Nov;83(11):4065-74. — View Citation

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