CompletedNot Applicable

Using D-Galactose as a Food Supplement in Congenital Disorders of Glycosylation

United States8 participantsStarted 2014-07

Plain-language summary

The goal of this study is to better characterize the metabolic alterations and sugar structure alterations (glycosylation abnormalities) in patients diagnosed with Congenital Disorders of Glycosylation. The investigators aim to assess the safety and tolerability of oral galactose treatment in a small pilot group of Congenital Disorders of Glycosylation patients. The investigators will also determine the relationship between simple milk sugar intake (galactose dose) in the diet and the blood and urine markers of protein glycosylation abnormalities.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Biochemically and genetically proven Congenital Disorders of Glycosylation. Exclusion Criteria: * Any of the following conditions: * Aldolase B Deficiency * Galactosemia (unable to process galactose) * Hemolytic uremic syndrome * Severe anemia * Diagnosis of intellectual disability or developmental delay * Galactose Intolerance * Has previously experienced any of the following severe side effects from oral galactose: * Diarrhea * Vomiting * Constipation * Galactosuria (Galactose in the urine) * Increased liver glycogen storage.

What they're measuring

Metabolic Function

Timeframe: 18 weeks

Trial details

NCT IDNCT02955264

SponsorTulane University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11

View on ClinicalTrials.gov More Congenital Disorders of Glycosylation trials