We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00459732
Recruitment Status : Completed
First Posted : April 12, 2007
Results First Posted : September 30, 2011
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital of Philadelphia
University of California, San Francisco
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.

Condition or disease Intervention/treatment Phase
Thalassemia Dietary Supplement: Zinc Dietary Supplement: Placebo Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Zinc and Bone Metabolism in Thalassemia
Study Start Date : April 2006
Actual Primary Completion Date : October 2009
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals Thalassemia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: "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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months) [ Time Frame: Baseline to 18 months ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459732


Locations
Layout table for location information
United States, California
Children's Hospital & Research Center, Oakland
Oakland, California, United States, 94609
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital of Philadelphia
University of California, San Francisco
Investigators
Layout table for investigator information
Principal Investigator: Ellen B. Fung, PhD, RD UCSF Benioff Children's Hospital Oakland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT00459732    
Obsolete Identifiers: NCT00480415
Other Study ID Numbers: 2004-106
K23HL076468 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2007    Key Record Dates
Results First Posted: September 30, 2011
Last Update Posted: December 4, 2020
Last Verified: December 2020
Keywords provided by UCSF Benioff Children's Hospital Oakland:
zinc, thalassemia, bone mineral density
Additional relevant MeSH terms:
Layout table for MeSH terms
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Physiological Effects of Drugs
Astringents
Dermatologic Agents