Hemoglobin and Iron Recovery Study (HEIRS)
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Purpose
The purpose of this study is to investigate the effect of daily iron supplements after blood donation on time to recovery of hemoglobin and iron stores. The study will also determine whether the effect of iron supplements on time to recovery is different in men and women, in older vs. younger donors (<60 years old vs. at least 60 years old) and in donors with replete vs. diminished pre-donation iron stores.
| Condition | Intervention | Phase |
|---|---|---|
|
Recovery of Hemoglobin and Iron Stores After Blood Donation |
Dietary Supplement: ferrous gluconate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hemoglobin and Iron Recovery Study |
- Time to recovery of hemoglobin after blood donation [ Time Frame: Up to 24 weeks after blood donation ] [ Designated as safety issue: No ]Hemoglobin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of hemoglobin to 80% of the pre-donation level.
- Iron stores [ Time Frame: Up to 24 weeks after blood donation ] [ Designated as safety issue: No ]Ferritin will be measured 3-7 days and 2, 4, 8, 12, 16 and 24 weeks after blood donation. A nonlinear regression of hemoglobin vs time since donation will be used to determine time to recovery of to pre-donation iron stores.
- Total body iron [ Time Frame: 24 weeks after blood donation ] [ Designated as safety issue: No ]Soluble transferrin receptor (sTfR) in blood will be measured 3-7 days and 24 weeks after blood donation. The ratio of sTfR to ferritin will provide a measure of total body iron at the two time points. Recovery of total body iron will be estimated from the difference between the ratios at the two time points.
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Iron supplements
Subjects who are randomized to receive daily iron supplements after donating blood
|
Dietary Supplement: ferrous gluconate
daily capsule of ferrous gluconate containing 38 mg of elemental iron
|
|
No Intervention: Control
Subjects who are randomized not to receive daily iron supplements after donating blood
|
Detailed Description:
The effect of taking iron supplements after blood donation on time to recovery of hemoglobin has been documented but it is not clear whether the benefits of iron supplements vary with age, gender or iron stores. To study this issue, individuals who are eligible to donate blood, based on hemoglobin level, will be randomized to receive daily iron supplements or no supplements. Randomization will be stratified on gender (male or female), age (<60 years old vs. at least 60 years old) and iron status (serum ferritin >26 vs serum ferritin no greater than 26). Subjects will be followed for 24 weeks with periodic blood draws to determine time to recovery of hemoglobin and iron stores. A 7 ml (about 1.5 teaspoons) blood sample will be drawn at each of seven study visits over the 24 weeks to track recovery of hemoglobin and iron.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- potential blood donors with hemoglobin of at least 12.5 gm/dL
- no blood donation for at least 4 months
- successful donation of a unit of whole blood
Exclusion Criteria:
- individuals who are taking iron supplements including multivitamins containing iron and refuse to stop do so for the 24 weeks of the study.
- baseline ferritin >300 ug/L (to exclude individuals with hemochromatosis)
Contacts and Locations| United States, California | |
| Blood Centers of the Pacific | |
| San Francisco, California, United States, 94118 | |
| United States, Connecticut | |
| American Red Cross, Connecticut Region | |
| Farmington, Connecticut, United States, 06032 | |
| United States, Pennsylvania | |
| Institute for Transfusion Medicine | |
| PIttsburg, Pennsylvania, United States, 15213 | |
| United States, Wisconsin | |
| Blood Center of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Joe Kiss, MD | Institute for Transfusion Medicine |
More Information
No publications provided
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT01555060 History of Changes |
| Other Study ID Numbers: | 714 |
| Study First Received: | March 9, 2012 |
| Last Updated: | March 13, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
hemoglobin recovery iron recovery iron supplements |
Additional relevant MeSH terms:
|
Ferrous gluconate Iron Hematinics Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013