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A clinical trial to evaluate the benefits of starting oral iron supplements in the first trimester of pregnancy in reducing the occurrence of anemia during pregnancy

A randomized controlled double-blind trial to evaluate the benefits of starting oral iron supplements in the first trimester, in reducing prevalence of anemia during pregnancy - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084204
Enrollment
380
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: O990- Anemia complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Oral iron and folate supplementation started in first trimester : Oral iron and folate supplementation (30 mg elemental iron + 500 mcg folic acid) daily, started at time of recruitment

Sponsors

Indian Council of Medical Research (ICMR)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women who conceived naturally With singleton uncomplicated pregnancies Who plan to deliver their babies in CMC, Vellore Willing to be randomised to an intervention and to be followed up Those who continue till delivery, with no complications of pregnancy

Exclusion criteria

Exclusion criteria: Those with multiple fetuses Those with any documented complication of pregnancy Those who develop any complication of pregnancy subsequently, after recruitment

Design outcomes

Primary

MeasureTime frame
1. Comparison of the proportion of anemic and/or iron-deficient women among those who receive and do not receive oral iron supplements (OIS) in the first trimester 2. Comparison of hematological and iron-related indices in women who receive and do not receive OIS in the first trimesterTimepoint: At the time of delivery of each woman in the study

Secondary

MeasureTime frame
1. Comparison of hematological & iron-related indices in cord blood from women who receive & do not receive OIS in the first trimester 2.Compare iron-related parameters in placentae of a subgroup of women who receive & do not receive OIS in the first trimesterTimepoint: At the time of delivery of each woman in the study

Countries

India

Contacts

Public ContactMolly Jacob

Christian Medical College, Vellore

mjacob@cmcvellore.ac.in09894494337

Outcome results

None listed

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