A randomised, double blind, placebo controlled trial of the effectiveness of post donation” short term iron replacement in female whole blood donors with a daily oral dose of 45 mgs elemental iro

Phase 3

Completed

• Conditions: Iron deficiency in female blood donors aged 18-45 years; Blood - Anaemia

• Registration Number: ACTRN12609000496213
• Lead Sponsor: Australian Red Cross Blood Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

To be eligible to participate an individual must:
1. Be a registered female blood donor aged 18-45 years who has donated successfully on at least one occasion in the last 2 years and who is eligible to donate on their first study visit in accordance with Guidelines for the Selection of Blood Donors” Australian Red Cross Blood Service (ARCBS)Standard Operating Procedure (SOP) (DAP-L2-001);
2. Have a reasonable expectation of adherance to the ARCBS Donor Acceptance Criteria (as per Guidelines for the Selection of Blood Donors” ARCBS SOP DAP-L2-001) to enable the participant to donate at their 12 week follow-up visit;
3.Be able to provide written informed consent to participate in the trial;
4.Be contactable by phone for the duration of the study period;
5.Not be pregnant or breast feeding;
6.Not be intending to become pregnant in the next 6 months;
7.Agree to use an effective, medically reliable method of preventing conception (such as condoms, the combined oral contraceptive pill, an intrauterine device [IUD], some implants, injectables, sexual abstinence or a vasectomised partner) for the duration of the trial, unless surgically sterile, if the participant is sexually active and of child bearing potential. 8.Be able and willing to comply with the Protocol;
9.Not be travelling outside of Australia during their participation in the trial;
10.Be able to attend the 12-week follow-up visit;
11.Special notes for inclusion
11.1 ARCBS staff members are able to participate if willing and meet the above inclusion criteria;
11.2 Individuals who have had previous deferrals for iron deficiency or iron deficiency anaemia are able to participate if they meet the inclusion criteria

Exclusion Criteria

An individual is not eligible to participate in this trial if they:
1.Have a 20 g/L decrease in Haemoglobin (Hb) from their previous donation;
2.Are therapeutic donors;
3.Have polycythaemia, haemochromatosis (including those who are homozygous or compound heterozygous as identified by genetic screening and may or may not have developed iron overload), or porphyria cutanea tarda (PCT), or other conditions associated with iron overload or elevated iron levels whether or not the cause is known;
4.Have a family history of haemochromatosis (and have not been tested to exclude genetic predisposition to the condition);
5.Have a current or prior history of conditions affecting the gastrointestinal system including but not limited to: gastric or duodenal ulcers, helicobacter, inflammatory bowel disease, coeliac disease, Crohn’s disease, irritable bowel syndrome, reflux, lactose intolerance, stomas, ileostomy, any gastrointestinal blood loss, bowel cancer, polyps, diverticular disease or constipation requiring regular medication (unless only requiring simple over the counter laxative treatment as recommended by a doctor less than once per month and no history of hospital attendance or admission or causing abdominal pain or needing enemas);
6.Currently having symptoms and/or being investigated for any bowel symptoms;
7.Have liver or pancreatic problems not including diabetes;
8.Have a history of red cell abnormalities including hereditary elliptocytosis, Glucose 6Phosphatase Dehydrogenase (G6PD)deficiency, hereditary spherocytosis or any known form of haemoglobinopathy including all thalassaemia phenotypes and sickle cell trait;
9.Have a history of an inflammatory or autoimmune condition or illness e.g. rheumatoid arthritis, systemic lupus erythematosus (SLE);
10.Have a past history or are currently under treatment for vitamin B12 or folate deficiency or any other non-iron deficiency anaemia;
11.Have a current diagnosis of asthma requiring any form of medication including inhalers in the previous 2 years;
12.Are currently taking iron tablets or vitamin supplements containing a daily equivalent of more than 5 mg elemental iron;
13.Are currently being treated for iron deficiency or iron deficiency anaemia including those currently on a course of iron tablets to replenish stores;
14.Prior to the commencement of the trial are regularly taking aspirin or non sterodial anti-inflammatory drugs (NSAIDs); regularly is defined as taking aspirin or NSAIDs more than once per week;
15.Are currently taking any of the following medications: H2 antagonists (ranitidine, cimetidine, famotidine, nizatidine), proton pump inhibitors (including omeprazole, esomeprazole, lansoprazole), bisphosphonates (alendronate, clodronate, etidronate, ibandronic acid, pamidronate, risedronate, tiludronate, zoledronic acid), levodopa or carbidopa, methyldopa, penicillamine, quinolones (ciprofloxacin, moxifloxacin, norfloxacin, ofloxacin [excluding topical antibiotic preparations]), tetracyclines or thyroid hormones (thyroxin, liothyronine);
16.Are currently taking antacids more than once per month;
17.Are currently taking calcium supplements as an evening dose;
18.Have had episodes of chronic urticaria of unknown cause or any allergic reaction where episodes have been associated with systemic features such as bronchospasm, hypotension, upper airways swelling or anaphylaxis, or where there is the potential for a systemic reaction necessitating carrying an Epipen '

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Iron deficiency anaemia as determined by changes in haemoglobin in a venous blood sample and total body iron (TBI) as determined by ferritin concentration and soluble transferrin receptor concentration in serum from Index donation to Week 12 in donors receiving iron supplementation versus placebo[Haemoglobin(venous) and TBI is measured at the time of blood donation and then at 12 weeks after donation to determine total change];The change in total body iron (TBI) as determined by ferritin concentration and soluble transferrin receptor concentration in serum from Index donation to Week 12 in donors receiving iron supplementation versus placebo[TBI is measured at the time of blood donation and then at 12 weeks after donation to determine total change]

Secondary Outcome Measures

Name	Time	Method
Eligibility to donate at the Week 12 visit as determined by i) capillary haemoglobin and ii) venous haemoglobin.[12 weeks after initial blood donation];The incidence of gastrointestinal complaints in participants as determined by a self-administered diary, self reported compliance and tablet counts[1, 4 8 and 12 weeks after initial blood donation]