RightFit
RecruitingPhase 2

Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
15 Years to 40 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention."
  • "The study is a 16-week program, involving 2 baseline blood draws 4 weeks apart, followed by a randomized 12-week zinc intervention."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two daily zinc doses, 25 mg and 40 mg, in people ages 15–40 with certain types of sickle cell disease. It will look at blood markers of bone breakdown and rebuilding, and find the highest dose people can tolerate. The study lasts 16 weeks, including 12 weeks of taking zinc.

The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-40 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 6 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 15–40 years old.
  • You have sickle cell disease type SS or sickle beta-zero thalassemia.
  • It has been at least 2 weeks since your last pain crisis.
  • Males and females can join.

Who can't join

  • You take a supplement with zinc and cannot or will not stop it for 3 months before the study starts.
  • Your vitamin D blood level is below 20 ng/mL.
  • You receive more than 8 blood transfusions a year and have too much iron: liver iron above 7 mg/g or average ferritin, an iron-related blood marker, above 4,000 ug/L.
  • You cannot swallow pills or take a daily supplement as directed.
  • You are in another study testing a drug.
  • You have been diagnosed with long-term kidney disease, with a kidney filtering rate (eGFR) below 30 mL/min/1.73 m².

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age: ≥ 15.0 to ≤ 40.0 years * Diagnosis: SCD-SS or SCD-S Beta zero Thalassemia, in steady state (defined as a minimum of 2 weeks days following pain crisis) * Male or Female Exclusion Criteria: * Taking any supplement containing zinc and unable/willing to stop for 3 months prior to study start * 25-Hydroxy Vitamin D \< 20 ng/mL * On chronic transfusion therapy (defined as \>8 Transfusions/year) and iron overloaded (defined as liver iron concentration \> 7 mg/g OR average serum ferritin \>4000 ug/L) * Unable swallow pills or take daily supplement as instructed * Currently participating in another investigational drug trial * Prior diagnosis of chronic kidney disease (eGFR \< 30 mL/min/1.73m2)

Study sites (6)

CA

NC

OH

PA

TX