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NCT02245321 · ClinicalTrials.gov registry record · NA
Strategies to Reduce Iron Deficiency
A NA study, sponsored by Westat.
- Completed
- Registry status
- NA
- Development phase
- 702
- Enrollment target
NCT02245321 is a NA study that has completed, run by Westat. The registered enrollment target is 702 participants.
The verdict
NCT02245321, a NA study, has completed, sponsored by Westat.
- COMPLETED
- Registry status
- NA
- Development phase
- 702 participants
- Enrollment target
Study Summary
The prevalence of iron deficiency in blood donors has been demonstrated to be a direct consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is priority to implement programs to remediate iron deficiency issues associated with blood donations. To explore this issue, the study's aims to: 1. Determine whether regular blood donors provided with accurate information about their iron status and written recommended courses of action will take steps to prevent/mitigate iron deficiency on their own without being given iron supplements by the blood center; and 2. Determine if two different amounts of iron provided by the blood center will prevent/mitigate iron deficiency in regular blood donors. To conduct this randomized, placebo controlled study, participant donors will be assigned to one of two arms and followed for a 24 month period. Each subject will provide additional blood samples of 7 ml and 4.5 ml at each study visit for the purpose of tracking hemoglobin (Hgb), ferritin, soluble transferrin receptor (sTfR), and hematology laboratory results. Under the two study arms, subjects are to be randomized into one of the following five blinded categories: * Receive a thank you letter after each blood donation. * Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation. * Receive pills to take daily that contain no iron (a placebo or inert pill). * Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron). * Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Ferrous gluconate- 19 mg
- DIETARY_SUPPLEMENT Ferrous gluconate- 38 mg
- OTHER Letter Group- Information Provided
- OTHER Letter - No Information Provided
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02245321
The ClinicalTrials.gov registry entry for NCT02245321 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 702 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Westat, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02245321 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02245321 about?
NCT02245321 is a clinical study titled "Strategies to Reduce Iron Deficiency". The prevalence of iron deficiency in blood donors has been demonstrated to be a direct consequence of repeat blood donations. Given the adverse effects of iron deficiency, it is priority to implement programs to remediate iron deficiency issues associated with blood donations. To explore this issue,...
What is the current status of trial NCT02245321?
This trial is currently completed. It is a NA study. The enrollment target is 702 participants. The study started on 2011-06. Estimated completion is 2014-06.
What interventions are being tested in trial NCT02245321?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Ferrous gluconate- 19 mg (DIETARY_SUPPLEMENT), Ferrous gluconate- 38 mg (DIETARY_SUPPLEMENT), Letter Group- Information Provided (OTHER), Letter - No Information Provided (OTHER).
Who is sponsoring clinical trial NCT02245321?
This trial is sponsored by Westat, which has 13 total clinical trials registered on ClinicalTrials.gov.
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