Study to check the role of iron supplementation in helping maintain iron stores in the blood donor
- Registration Number
- CTRI/2017/02/007860
- Lead Sponsor
- PGIMER Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 300
1.Blood donor must qualify for blood donation in accordance with the legislation laid down in the Drugs and cosmetics Act of 1940, and the rules therein of 1945 as amended from time to time.
1.Participant should not be on hematinic therapy or have iron deficiency.
2.Participant must not have any allergy to iron formulations.
3Participant must not have history suggestive of peptic ulcers, gastro-oesophageal reflux disease, celiac disease, haemorrhoids or any history of occult blood loss every in life time.
4.Donors reactive for any transfusion transmissible infectious infection (Antibodies to HIV ½, HBsAg, antibodies to HCV, Syphilis and malaria) as per the mandatory testing in compliance with the regulations in India.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum ferritin, soluble transferring receptor, hepcidin and C reactive proteinTimepoint: ï?§First Sampling: 5 ml Plain red capped and 5 ml EDTA blood sample at baseline in vacutainerâ??s at first donation (D1). <br/ ><br>ï?§Second sample on donation (D2) after (after 35 days of iron supplementation). <br/ ><br>ï?§Third sample on donation (D3) after (after 35 days of iron supplementation). <br/ ><br>ï?§Fourth sample on donation (D4) after (after 35 days of iron supplementation). <br/ ><br>
- Secondary Outcome Measures
Name Time Method serial measurements of the iron reserves will be analysed to find out as to how much role iron supplementation has in preventing the depletion of the body stores in blood donors.Timepoint: ï?§Second sample on donation (D2) after (after 35 days of iron supplementation). <br/ ><br>ï?§Third sample on donation (D3) after (after 35 days of iron supplementation). <br/ ><br>ï?§Fourth sample on donation (D4) after (after 35 days of iron supplementation). <br/ ><br>