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

Completed · Not applicable

Conditions studied: Congenital Disorders of Glycosylation

In brief

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.

Key facts

Study ID

NCT02955264

Run by

Tulane University

People needed

8

Starts

2014-07-01

Expected to finish

2018-01-01

Last updated by the study team

2021-01-08

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biochemically and genetically proven Congenital Disorders of Glycosylation.

You may not qualify if…

• 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.

Where it is running

• Tulane University — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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