Sex Differences in Statural Growth Impairment in Pediatric Crohn's Disease (Growth Study)
Published: 09/24/2018
General Information:
To investigate the underlying mechanisms of sex differences in statural growth impairment and to develop a predictive model to identify patients at highest risk for developing growth impairment refractory to standard therapeutic approaches
Eligibility:
Eligibility:
- Crohn’s disease
- Males ages 6 to 15 years
- Females ages 5 to 13 years
Detailed eligibility reviewed when patient contacts the Study Team
Study Details:
Study Description
If the patient is eligible to participate after the Screening Visit, she/he will meet with the Growth Study Team five times over two years (approximately once every 6 months) and do the following:
- Answer questions about her/his medical history and physical development
- Get up to 2 more x-rays of her/his left hand to determine her/his bone age (skeletal maturation)
- Have her/his height and weight measured
- Have blood drawn
- Record what she/he eats and drinks (undergo nutrient intake assessment)
OPTIONAL procedures include allowing a doctor to perform a physical exam to stage her/his physical development and allow storage of blood for future testing.
Description of Treatment or Intervention (Mechanism of Action)
This is an observational study. No treatment/intervention is involved in this study.
Patient Participation Requirements
Prospective participants are screened for study eligibility. Screening will include answering questions about the participant's medical history and physical development and obtaining an x-ray of her/his left hand to determine bone age. Height and weight measurements will also be obtained. If eligible to participate after the Screening Visit, participants will meet with the Growth Study Team five more times over two years (approximately once every 6 months) and answer questions about her/his medical history and physical development, get up to 2 more x-rays of her/his hand to determine her/his bone age, have her/his height and weight measured, have blood drawn, and record what she/he eats and drinks (undergo nutrient intake assessment). Optional procedures will include allowing a doctor to perform a physical exam to stage her/his physical development and allow storage of blood for future testing and genetic testing. Biological parents will be asked if Study Team can measure their heights once during the study.
Possible Risks & Side Effects
There are no major risks associated with the study.