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Zinc & Bone Health in Thalassemia: The Think Zinc Study

NCT ID: NCT00459732

Last Updated: 2020-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Thalassemia

Keywords

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zinc, thalassemia, bone mineral density

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Capsule

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Zinc (25 mg/d)

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

Group Type ACTIVE_COMPARATOR

Zinc

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Zinc

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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zinc sulphate elemental zinc "sugar" pill

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen B. Fung, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland

Locations

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Children's Hospital & Research Center, Oakland

Oakland, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23945720 (View on PubMed)

Other Identifiers

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K23HL076468

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2004-106

Identifier Type: -

Identifier Source: org_study_id

NCT00480415

Identifier Type: -

Identifier Source: nct_alias