Zinc & Bone Health in Thalassemia: The Think Zinc Study (ThinkZn)

December 3, 2020 updated by: UCSF Benioff Children's Hospital Oakland

Zinc and Bone Metabolism in Thalassemia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary aim of this study is to determine if zinc supplementation improves bone health in young patients with thalassemia. Osteoporosis is a significant co-morbidity in patients with thalassemia which leads to decreased quality of life. The most effective way to prevent osteoporosis is to build strong, dense bones in the early years. A combination of disease, endocrine and nutritional factors likely contribute to the etiology of osteoporosis in this population. However, even well transfused patients with normal gonadal function who are supplemented with calcium have low bone mass. It is hypothesized that patients with thalassemia have low bone mass, in part, due to zinc deficiency. Sub-optimal zinc status has been identified in patients with thalassemia and zinc supplementation has been shown to improve linear growth. To test the primary hypothesis, an 18 month randomized placebo-controlled trial of zinc supplementation (25 mg Zn/day) vs. placebo will be conducted in 60 young patients (6-30 yrs) with thalassemia and low bone mass (spine BMD Z-score <-1.0). Bone health, as estimated from measurements of bone mass (by DXA and pQCT) and markers of bone formation and resorption will be the primary outcome variables. This will be the first study to examine the effects of zinc. supplementation on bone health in patients with thalassemia. If zinc supplementation is found to have a clinically important effect, this simple, safe, non-invasive therapy could quickly become a part of the standard care of these young patients and improve overall health in children and adult patients with thalassemia

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
        • Children's Hospital & Research Center, Oakland
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Capsule
placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months
Dietary supplement: Placebo
Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months
Other Names:
  • "sugar" pill
Active Comparator: Zinc (25 mg/d)
25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months
Dietary supplement: Zinc
25 mg of elemental zinc as zinc sulphate take once daily for 18 months
Other Names:
  • zinc sulphate
  • elemental zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)
Time Frame: 0 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)
Time Frame: Baseline to 18 months
Baseline to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteocalcin, a Marker of Bone Formation
Time Frame: Baseline to 18 months
Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups
Baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCSF Benioff Children's Hospital Oakland

Collaborators

Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Francisco

Investigators

  • Principal Investigator: Ellen B. Fung, PhD, RD, UCSF Benioff Children's Hospital Oakland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (Estimate)

April 12, 2007

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 3, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-106
  • K23HL076468 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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