NCT01772680

Brief Summary

The primary aim of this study is to measure zinc status and related proteins in patients with Thalassemia who have or do not have diabetes. The secondary aim will be to explore the effect of zinc supplementation on glucose metabolism in patients with thalassemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

January 17, 2013

Last Update Submit

November 20, 2020

Conditions

Thalassemia

Keywords

ThalassemiaDiabetesZincIron-Overload

Outcome Measures

Primary Outcomes (1)

  • Oral glucose Tolerance Test

    Effect of 3 months of zinc supplementation on oral glucose tolerance test results

    3 months

Secondary Outcomes (1)

  • Fructosamine

    3 months

Study Arms (1)

Zinc Supplementation

EXPERIMENTAL

25 mg elemental Zinc as Zn sulfate in capsule form taken daily for 3 months

Dietary Supplement: Zinc Supplementation

Interventions

Zinc SupplementationDIETARY_SUPPLEMENT

25 mg elemental zinc taken as zinc sulfate in capsule form taken daily for 3 months

Zinc Supplementation

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed with transfusion dependent thalassemia
  • \> 12 years of age

You may not qualify if:

  • patients who are pregnant
  • patients who are on growth hormone therapy
  • patients who currently have diabetes (therefore cannot have an oral glucose tolerance test)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital & Research Center Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

ThalassemiaDiabetes MellitusIron Overload

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesIron Metabolism Disorders

Study Officials

  • Ellen B Fung, PhD RD

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 21, 2013

Study Start

November 1, 2012

Primary Completion

January 1, 2015

Study Completion

May 1, 2015

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations

US(1)