NCT00867971

Brief Summary

Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 24, 2009

Status Verified

February 1, 2009

Enrollment Period

1.7 years

First QC Date

March 22, 2009

Last Update Submit

March 22, 2009

Conditions

Growth Hormone TreatmentGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraoccular pressure in children treated with RGH

    2 years

Study Arms (2)

RGH treated

Other: Measuring intraoccular pressure

Starting treatment with RGH

Other: Measuring intraoccular pressure

Interventions

Measuring intraoccular pressureOTHER

Measurement of intraoccular pressure by tonometry

RGH treatedStarting treatment with RGH

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children age 6-18 treated with growth hormone

You may qualify if:

  • Age 6-18 years
  • treatment with recombinant growth hormone

You may not qualify if:

  • Underlying Chronic diseases
  • Family history of eye diseases
  • elevated occular pressure prior to starting treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf harofeh medical center

Ẕerifin, Israel

Location

Related Publications (1)

  • Youngster I, Rachmiel R, Pinhas-Hamiel O, Bistritzer T, Zuckerman-Levin N, de Vries L, Naugolny L, Eyal O, Braunstein R, Rachmiel M. Treatment with recombinant human growth hormone during childhood is associated with increased intraocular pressure. J Pediatr. 2012 Dec;161(6):1116-9. doi: 10.1016/j.jpeds.2012.05.024. Epub 2012 Jun 23.

    PMID: 22727870DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 22, 2009

First Posted

March 24, 2009

Study Start

February 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 24, 2009

Record last verified: 2009-02

Locations

IL(1)