NCT00459732

Brief Summary

The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 30, 2011

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

3.5 years

First QC Date

April 11, 2007

Results QC Date

November 4, 2010

Last Update Submit

December 3, 2020

Conditions

Thalassemia

Keywords

zinc, thalassemia, bone mineral density

Outcome Measures

Primary Outcomes (2)

  • Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)

    Change in pa spine bone mineral density by DXA between baseline and 18 months

    0 to 18 months

  • Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)

    Baseline to 18 months

Secondary Outcomes (1)

  • Osteocalcin, a Marker of Bone Formation

    Baseline to 18 months

Study Arms (2)

Placebo Capsule

PLACEBO COMPARATOR

placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months

Dietary Supplement: Placebo

Zinc (25 mg/d)

ACTIVE COMPARATOR

25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months

Dietary Supplement: Zinc

Interventions

ZincDIETARY_SUPPLEMENT

25 mg of elemental zinc as zinc sulphate take once daily for 18 months

Also known as: zinc sulphate, elemental zinc
Zinc (25 mg/d)
PlaceboDIETARY_SUPPLEMENT

Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months

Also known as: "sugar" pill
Placebo Capsule

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 30 years of age
  • thalassemia
  • bone mineral density Z-score \< -1.0 (by DXA)

You may not qualify if:

  • Bone marrow transplant recipient
  • Currently prescribed treatment for low bone mass other than calcium or vitamin D (e.g. calcitonin, bisphosphonates)
  • Currently prescribed zinc supplementation who are unable or unwilling to stop during this trial
  • Currently participating in another trial with a medication known to affect bone mineral density.
  • Chronic use of systemic corticosteroids
  • Untreated hypogonadism or growth hormone deficiency
  • Baseline serum copper \< 70 µg/dL
  • Baseline vitamin D-25OH \< 11 ng/mL
  • Pregnant or lactating at study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital & Research Center, Oakland

Oakland, California, 94609, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Fung EB, Kwiatkowski JL, Huang JN, Gildengorin G, King JC, Vichinsky EP. Zinc supplementation improves bone density in patients with thalassemia: a double-blind, randomized, placebo-controlled trial. Am J Clin Nutr. 2013 Oct;98(4):960-71. doi: 10.3945/ajcn.112.049221. Epub 2013 Aug 14.

    PMID: 23945720DERIVED

MeSH Terms

Conditions

Thalassemia

Interventions

ZincZinc SulfateSugars

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsZinc CompoundsCarbohydrates

Results Point of Contact

Title
Ellen Fung, PhD RD CCD
Organization
Children's Hospital & Research Center, Oakland
efung@mail.cho.org
510-428-3885

Study Officials

  • Ellen B. Fung, PhD, RD

    UCSF Benioff Children's Hospital Oakland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 12, 2007

Study Start

April 1, 2006

Primary Completion

October 1, 2009

Study Completion

February 1, 2011

Last Updated

December 4, 2020

Results First Posted

September 30, 2011

Record last verified: 2020-12

Locations

US(3)