ThalassemiaThinkZnNCT00459732
Zinc & Bone Health in Thalassemia: The Think Zinc Study
A study testing Zinc in people with Thalassemia, run by UCSF Benioff Children's Hospital Oakland at 3 sites in United States.
Trial summary
The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia. Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Thalassemia
- What is being tested?
- Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2006to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 6 to 30 years of age
- thalassemia
- bone mineral density Z-score < -1.0 (by DXA)
Who cannot join
- 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
Show all 9Show fewer
- Baseline serum copper < 70 µg/dL
- Baseline vitamin D-25OH < 11 ng/mL
- Pregnant or lactating at study entry
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital & Research Center, Oakland
Oakland, California, 94609
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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
- Conditions
- Thalassemia
- Being tested
- Zinc, Placebo
- Keywords
- zinc, thalassemia, bone mineral density
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDietary supplement
Also called zinc sulphate, elemental zinc
25 mg of elemental zinc as zinc sulphate take once daily for 18 months
PlaceboDietary supplement
Also called "sugar" pill
Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo Capsule | Placebo comparator | placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months Receives: Dietary Supplement: Placebo |
| Zinc (25 mg/d) | Active comparator | 25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months Receives: Dietary Supplement: Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to 18 months
Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)
Measured: Baseline to 18 months
Secondary outcomes (1)
Osteocalcin, a Marker of Bone Formation
Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startApr 2006
- Primary completionOct 2009
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThalassemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital of Philadelphia, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Ellen B. Fung, PhD, RD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459732
- Sponsor's protocol ID
- 2004-106
- Other IDs
- K23HL076468
- Acronym
- ThinkZn
- Status last verified
- Dec 2020
- First submitted
- 11 Apr 2007
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 23945720
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc and Bone Metabolism in Thalassemia
- ClinicalTrials.gov ID
- NCT00459732
- Acronym / sponsor ID
- ThinkZn / 2004-106
- Conditions
- Thalassemia
- Keywords
- zinc, thalassemia, bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Children's Hospital of Philadelphia, University of California, San Francisco
- Study start
- Apr 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Apr 2007 (estimated)
- Results
- Posted 30 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Capsule | Placebo comparator | Dietary Supplement: Placeboplacebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months |
| Zinc (25 mg/d) | Active comparator | Dietary Supplement: Zinc25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 6 to 30 years of age
- thalassemia
- bone mineral density Z-score < -1.0 (by DXA)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZincAlso: zinc sulphate, elemental zinc25 mg of elemental zinc as zinc sulphate take once daily for 18 months | Dietary supplement | Zinc (25 mg/d) |
| PlaceboAlso: "sugar" pillPlacebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months | Dietary supplement | Placebo Capsule |
Primary outcome
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
1 secondary outcome
Osteocalcin, a Marker of Bone Formation
Time frame: Baseline to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23945720Fung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen B. Fung, PhD, RD principal investigator
UCSF Benioff Children's Hospital Oakland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc in people with Thalassemia, run by UCSF Benioff Children's Hospital Oakland at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) (time frame: 0 to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.