None listed
Conditions
Interventions
Intervention1: Carbonyl Iron (100 mg elemental iron)and iron supplement (50 mg elemental iron).: Three arms of study will enroll blood donors and supplement with carbonyl iron with 100 mg elemental ir
Sponsors
PGIMER Chandigarh
Only Intramural funding from PGIMER Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Participant should not be on hematinic therapy or have iron deficiency. 2. Participant must not have any allergy to iron formulations. 3 Participant 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). ï?§ Second sample on donation (D2) after (after 35 days of iron supplementation). ï?§ Third sample on donation (D3) after (after 35 days of iron supplementation). ï?§ Fourth sample on donation (D4) after (after 35 days of iron supplementation). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). ï?§ Third sample on donation (D3) after (after 35 days of iron supplementation). ï?§ Fourth sample on donation (D4) after (after 35 days of iron supplementation). | — |
Countries
India
Contacts
Public ContactDr Suchet Sachdev
PGIMER Chandigarh
Outcome results
None listed