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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: Completed NA study, sponsored by Westat.

NCT02245321 is a NA study that has completed, run by Westat. The registered enrollment target is 702 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

a protein responsible for transporting oxygen in the blood

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

FieldValue
Enrollment Target 702 participants
Start Date 2011-06
Est. Completion 2014-06
Phase NA
Westat

13 total trials

What the finished NCT02245321 record still lists

NCT02245321 is an interventional study that assigns participants to a tested intervention. The registered 702 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT02245321 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02245321's enrollment target sits among peer trials

702 148th of 2000 higher than 1,852 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02245321, the US trial registry maintained by the National Library of Medicine. NCT02245321 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.