Is ferrous ascorbate superior to ferrous sulfate and ferrous fumarate in improving the haemoglobin level and serum ferritin level in pregnant women with iron deficiency anaemia during second and third trimester?

1. Settings Obstetric unit of Dr. M Dissanayake at Teaching hospital, Kalutara Professorial Obstetric unit at Teaching hospital, Peradeniya Professorial Obstetric unit at Teaching hospital, Batticaloa

2. Randomization

a. Method of Randomization: Stratified randomization. Each obstetric unit/ centre will be taken as a stratum. Within each stratum randomization will be carried out in blocks of 6 or 9 b. Unit of randomization : Individual patient c. Method of sequence generation: Three separate Computer- generated lists for the three sites. d. Method of allocation concealment: Sealed envelopes will be used for allocation concealment. Randomization numbers will be kept in serially numbered sealed envelopes. Once patients are recruited to the trial, The envelope with the serial number corresponding to the randomization number will be opened and the relevant treatment will be provided

1. Intervention: 1 tablet of ferrous ascorbate (Globac), which has 100 mg of elemental iron, 0.4 mg of folic acid and 525 mg of vitamin C

2. A- two tablets of ferrous sulfate (Ferrosal, 60mg of elemental iron in each) + 1 tablet Folic acid (1 mg) + 1 tablet of vitamin C 500mg (1 Cimune tablet has 500 mg of vitamin C and 11.25 mg of Zn) B - Two tablets of ferrous fumarate (2 tablets of Ferrup) (1 Ferrup tablet has 51 mg of elemental iron, 0.4 mg of folic acid, 15 ?g of vitamin B12 and 15 mg of Zinc) +1 tablet of vitamin C 500 mg (1 tablet of Cimune has 500 mg of vitamin C and 11.25 mg of Zn)

3. Blinding The medical team (healthcare providers, data collectors, outcome adjudicators, data analysts) will be blinded to the intervention by providing all three drugs in similar plastic containers. The participants would not be blinded as the packs inside the containers will indicate the drug name.

1. Pregnant female (gestational age 14 to 24 weeks).
2. Aged 18 years and above.
3. Hemoglobin levels <11 g/dl but >7 g/dl and serum ferritin < 30 µg/dl.
4. A diagnosis of iron deficiency anaemia based on the blood picture.

1. Hypersensitivity to iron supplements
2. Reported intolerance to iron supplements in the past
3. Severe anemia requiring parentral transfusion or transfusion of blood products
4. Known diagnosis of anemia related to causes other than iron deficiency (thalassemia, chronic disease, sickle cell, sideroblastic anaemia etc.)
5. Hemochromatosis or iron overload
6. Malabsorptive, ulcerative or inflammatory gastro-intestinal disease
7. History of serious progressive or chronic inflammatory disease (cardiac, renal, hepatic, oncological, autoimmune or any other systemic disease)
8. Undergone surgery in one month before enrolment or planned to undergo surgery during the course of study
9. Subject simultaneously participating in any other clinical studies or having participated in any other clinical trial in the past 3 months. OR
10. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, bariatric or bowel surgery, HIV infection, or severe coronary artery disease).