Zinc & Bone Health in Thalassemia: The Think Zinc Study

Study Overview
=================
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

Official Title
-----------------
Zinc and Bone Metabolism in Thalassemia

Conditions
-----------------
Thalassemia

Intervention / Treatment
-----------------
* Dietary Supplement: Zinc
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Capsule<br>placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months | Dietary Supplement: Placebo<br>* Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months<br>* Other names: sugar pill;|
| Active Comparator: Zinc (25 mg/d)<br>25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months | Dietary Supplement: Zinc<br>* 25 mg of elemental zinc as zinc sulphate take once daily for 18 months<br>* Other names: 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) | 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) |  | Baseline to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
zinc, thalassemia, bone mineral density