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

Tracking Information
First Submitted Date  ICMJE April 11, 2007
First Posted Date  ICMJE April 12, 2007
Results First Submitted Date  ICMJE November 4, 2010
Results First Posted Date  ICMJE September 30, 2011
Last Update Posted Date December 4, 2020
Study Start Date  ICMJE April 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2011)
  • 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
  • Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months) [ Time Frame: Baseline to 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
  • Change in Lumbar Spine Bone Mineral Density (BMD) by DXA
  • Change in Whole Body Bone Mineral Content (BMC) by DXA
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2011)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2007)
  • Changes in specific markers of bone turnover
  • Changes in growth parameters
  • Changes in body composition
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zinc & Bone Health in Thalassemia: The Think Zinc Study
Official Title  ICMJE Zinc and Bone Metabolism in Thalassemia
Brief Summary The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Thalassemia
Intervention  ICMJE
  • Dietary Supplement: Zinc
    25 mg of elemental zinc as zinc sulphate take once daily for 18 months
    Other Names:
    • zinc sulphate
    • elemental zinc
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo Capsule
    placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Zinc (25 mg/d)
    25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months
    Intervention: Dietary Supplement: Zinc
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2010)
45
Original Enrollment  ICMJE
 (submitted: April 11, 2007)
60
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00459732
Other Study ID Numbers  ICMJE 2004-106
K23HL076468 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCSF Benioff Children's Hospital Oakland
Study Sponsor  ICMJE UCSF Benioff Children's Hospital Oakland
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Children's Hospital of Philadelphia
  • University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Ellen B. Fung, PhD, RD UCSF Benioff Children's Hospital Oakland
PRS Account UCSF Benioff Children's Hospital Oakland
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP