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A clinical trial to compare the effects of 60 mg and 100 mg iron in pregnant women for the prevention of iron deficiency anaemia

Randomized controlled trial of 60 mg vs 100 mg elemental iron with fixed dose of 0.5 mg folic acid oral supplementation for iron deficiency anaemia prophylaxis in pregnant women at a secondary care hospital in Haryana

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010057
Enrollment
160
Registered
2017-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Prevention of iron deficiency anaemia in non anaemic pregnant women

Interventions

Intervention1: 60 mg elemental iron: 60 mg elemental iron with 0.5 mg folic acid once daily for 180 days Control Intervention1: 100 mg elemental iron: 100 mg elemental iron with 0.5 mg folic acid once

Sponsors

Dr Kapil Yadav
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Non anaemic pregnant women at 12 weeks of gestation or before. 2.Residing in the study area of Ballabgarh for the last 1 year. 3.Those willing to stay at current address throughout pregnancy and planning to deliver the baby at Ballabgarh region.

Exclusion criteria

Exclusion criteria: 1.Pregnant women already taking iron tablets for more than one month. 2.All high risk pregnancy.

Design outcomes

Primary

MeasureTime frame
Difference of change in mean haemoglobin and serum ferritin level of 60 mg and 100 mg groups.Timepoint: 180 days—

Secondary

MeasureTime frame
Difference in the compliance between 60 mg and 100 mgTimepoint: 180 days;Difference in the frequency and type of side effects between 60 mg and 100 mgTimepoint: 180 days—

Countries

India

Contacts

Public ContactDr Kapil Yadav

All India Institute of Medical Sciences (AIIMS) New Delhi

dr.arjunmc@aiims.ac.in011-26593233

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026