|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00065299 |
|
Date of registration:
|
21/07/2003 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Low Phenylalanine Diet for Mothers With Phenylketonuria (PKU)
|
|
Scientific title:
|
Effects of Maternal Phenylketonuria (PKU) on Pregnancy Outcome |
|
Date of first enrolment:
|
May 1984 |
|
Target sample size:
|
572 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00065299 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Bobbye M. Rouse, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Texas at Galveston |
|
|
Name:
|
Richard Koch, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Southern California |
|
|
Name:
|
Reuben Matalon, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Illinois at Chicago |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria
- Live in community setting
- Become pregnant or give birth during the term of the investigation
- Identified early in pregnancy
- Dietary therapy instituted prior to conception whenever possible
- Diagnosis of PKU based on results of Phe challenge, or clear diagnostic evidence in
medical record
- Blood Phe > 4 mg/dl
- Intellectually able to understand and comply with the requirements of the Phe
restricted diet, understand an informed consent, and adequately communicate with
clinic personnel
- IQ > 70
Inclusion Criteria for Controls
- Heterozygous sisters to HPA women
- Matched control from maternity facility; pregnancy and offspring from a non-PKU
female and a PKU male
Exclusion Criteria
- Women with evidence of pterin defect
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Phenylketonuria
|
|
Intervention(s)
|
|
Behavioral: Restricted phenylalanine diet
|
|
Secondary ID(s)
|
|
1N01HD23155
|
|
1N01HD23156
|
|
NICHD-PKU
|
|
1N01HD23148
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|