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The Use of Uncooked Sweet Manioc Starch to Treat Hepatic Glycogen Storage Diseases

NCT03871673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-09-26

No results posted yet for this study

Summary

Hepatic Glycogen Storage Diseases are a group of 10 serious genetic diseases that present in childhood and are characterized more frequently by the occurrence of repetitive hypoglycemia and dyslipidemia. Regarding treatment, the most commonly used strategy is the frequent administration of uncooked cornstarch, in average, every 4 hours. Although this treatment is successful, the use of large amounts of cornstarch can lead to overweight and, especially, to the decrease in the quality of life of patients and caregivers, due to the need to use the starch during the night. The search for a treatment that is widely available and that can lead to the prolongation of the fasting time, can collaborate to improve the care of these patients. The main scientific question to be answered by this research is: does sweet manioc starch, a Brazilian product, safely prolong the fasting time (with normoglycemia) of the patients as already suggested in experimental models? Main objective: To evaluate the efficacy and safety of the use of uncooked Sweet Manioc Starch in the treatment of patients with hepatic Glycogen Storage Diseases, using as model the Glycogen Storage Diseases type Ia.

Conditions

  • Glycogen Storage Disease Type I

Interventions

DIETARY_SUPPLEMENT

Sweet manioc starch

100 g of starch diluted in 200 ml of water at room temperature In the subsequent night the patient is crossed over to the other starch.

DIETARY_SUPPLEMENT

Cornstarch

100 g of starch diluted in 200 ml of water at room temperature In the subsequent night the patient is crossed over to the other starch.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Fundação Médica do Rio Grande do Sul

    collaborator UNKNOWN

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Ida D Schwartz, Dr · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-29
Primary Completion
2019-08-30
Completion
2021-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03871673 on ClinicalTrials.gov