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Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU) Clinical research trials and Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU) medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU). Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU) Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU) clinical trial. Participants frequently obtain the most expert healthcare available for their Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU) condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU)  Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU)
Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU)
For Condition: Phenylketonuria
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: Phenylketonuria (PKU) is a rare genetic condition. If not treated, PKU can cause severe mental retardation. Women with PKU are advised to eat a special diet when pregnant to prevent mental retardation in their children. This study will evaluate the effects of that diet on the children of mothers with PKU.
Details: PKU is an autosomal recessive trait caused by the absence of phenylalanine hydroxylase. Phenylalanine hydroxylase is an enzyme involved in the metabolism of phenylalanine (Phe). When phenylalanine hydroxylase is absent or defective, Phe levels rise and toxic Phe metabolites accumulate, causing central nervous system injury. PKU is a treatable disease. Affected individuals must adhere to a diet low in Phe during childhood. Women with PKU should also adhere to a low Phe diet before and during pregnancy to avoid fetal damage. The offspring of women with untreated maternal hyperphenylalaninemia (HPA) usually exhibit mental retardation, microcephaly, growth retardation, and other congenital anomalies. This study will examine the effect of a restricted Phe diet on reproductive outcome in women with maternal HPA. Participants in this study will be women with HPA whose blood Phe values are persistently greater than 4 mg/dl. Those women with blood Phe values consistently greater than 8 mg/dl will be placed on a Phe restricted diet to maintain plasma Phe concentrations between 2 and 8 mg/dl. This level of control is practical and achievable. Due to a gradient of increasing Phe level from mother to fetus, levels in the latter would vary from 3.5 to 12 mg/dl; these levels are usually associated with normal outcomes. Women will be monitored throughout their pregnancy on obstetric, biochemical, and nutritional parameters. Women on the Phe restricted diet will be given enough Phe-limited protein, calories, vitamins, and minerals to maintain adequate nutritional status. Folate supplementation will be provided. If indicated clinically, tyrosine (Tyr) and supplemental trace metals will be prescribed. A matching control sample of women and their offspring will be developed in collaboration with associated coordinating and collaborating centers. The offspring of both groups of mothers will be followed as long as the project permits. Those offspring born to mothers admitted to the project during the first 2 to 3 years of the study will be assessed on their intellectual ability and physical health, as well as academic achievement in school. Those admitted during the last 3 to 4 years of the study will be assessed on their intellectual ability and physical health, recognizing that limited data will be available for these offspring.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry 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
Total Enrollment: 572
Location and Contact Information:
Overall Study Official:
ReubenMatalon, Principal Investigator, University of Illinois
University of Texas Medical Branch at Galveston
Galveston, Texas,
United States
University of Illinois at Chicago
Chicago, Illinois,
United States
University of Southern California School of Medicine
Los Angeles, California, 90027
United States
Additional Information:
Study ID Numbers: NICHD-PKU; 1N01HD23148,1N01HD23155,1N01HD23156
Study Start Date: May 1984
Record last reviewed: May 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065299
Other Phenylketonuria Studies:
1. Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU)
2. Study of a Phenylalanine Restricted Diet During Pregnancy to Prevent Symptoms in Offspring of Patients With Phenylketonuria
Related Studies:
Other Phenylketonuria Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Low Phenylalanine Diet for Mothers with Phenylketonuria (PKU)
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