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Growth Arrest in Focal Dermal Hypoplasia

Completed
Conditions
Focal Dermal Hypoplasia
Registration Number
NCT02463656
Lead Sponsor
University of Colorado, Denver
Brief Summary

Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.

Detailed Description

Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
Inclusion Criteria
  • patients with focal dermal hypoplasia
  • between the ages of 3 and 18 years
  • ability to fast overnight, and
  • weight at least 9 kg
Exclusion Criteria
  • pregnant individuals,
  • weight less than 9 kg

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Determination of Growth Hormone Deficiency1 day

Glucagon growth hormone stimulation test

Secondary Outcome Measures
NameTimeMethod
Determination of poor growth1 day

Bone age x-rays will be read independently and compared to the accepted standards and quantified as a standard deviation from chronological age.

Determination of poor weight gain1 day

Evaluation of IGF-1 levels which are frequently low in children who are underweight or poorly nourished.

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