comparison of daily and weekly iron effect during pregnancy

Phase 4

Completed

Brief Summary: This randomized controlled clinical trial at a tertiary level hospital, recruited primi para women in 2 phases in their first trimester and supplemented oral iron in two schedules. One is 100 mg elemental iron daily and another is 200 mg elemental iron weekly. Detailed dietary history, oxidative stress parameters and micro-nutrients were tested to estimate the oxidative stress in normal pregnant women while supplementing iron in daily and weekly doses. After completion of 650 enrollments, data is under analysis for effect on total and subgroups, both ways.

Recruitment & Eligibility

Inclusion Criteria

Age 20-30 years Hemoglobin is above 11 gm/dl Middle socio-economic income group.

Exclusion Criteria

History of chronic ailment Taking any iron preparation already at the time of enrollment.

Primary Outcome Measures

Name	Time	Method
oxidative stress status in plasma of pregnant women taking oral iron in daily versus weekly doses for anemia prevention	At three point of time tests were conducted. Oxidative stress, micro nutrient and diet were assessed at the time of enrollment 14-16 weeks of primi pregnancy, after 3 months of supplementation and third time at 6 weeks post delivery

Secondary Outcome Measures

Name	Time	Method
effect of pregnancy on oxidative stress, relationship of oxidative stress with birth outcome and effect of daily versus weekly iron on side effects, acceptability and mode of delivery	At 3 point of time, blood samples and information were sought from study participants, at baseline (14-16 weeks pregnancy, thirst trimester, 6 weeks post delivery

Locations (1): HRRC AIIMS
🇮🇳
Delhi, DELHI, India
HRRC AIIMS
🇮🇳Delhi, DELHI, India
Dr Suneeta Mittal
Principal investigator
9313195247
suneeta_mittal@yahoo.com