Glycosade v UCCS in the Dietary Management of Hepatic GSD

Completed · Not applicable

Conditions studied: Glycogen Storage Disease

In brief

To compare efficacy of Glycosade® with uncooked corn starch (UCCS for the dietary management of hepatic glycogen storage diseases (GSD).

Key facts

Study ID

NCT02318966

Run by

Vitaflo International, Ltd

People needed

61

Starts

2016-02-22

Expected to finish

2020-08-14

Last updated by the study team

2024-02-16

Who can join

Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed by either genetic mutation analysis or enzymology study (this includes patients with only a single mutation but who also have supportive enzymology consistent with the condition). For those whom mutation analysis is not completed this will be assessed during the study.
• Aged 2 years or older (5 years or older in the USA)
• Established on full intake of uncooked corn starch therapy for at least 6 months

You may not qualify if…

• Women who are pregnant or breastfeeding at the start of the study or planning to become pregnant during the study will be excluded.
• children less than 2 years of age

Where it is running

• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Hôpital Antoine Béclère — Clamart, France
• Universitair Medisch Centrum Groningen — Groningen, Netherlands
• National Hospital for Neurology and Neurosurgery — London, Greater London, United Kingdom
• Evelina Children's Hospital — London, United Kingdom
• Great Ormond Street Hospital for Children — London, United Kingdom

Full record on ClinicalTrials.gov

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