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Effect of iron supplementation on the development of diabetes mellitus during pregnancy

Iron supplementation during pregnancy and the risk of gestational diabetes mellitus - Not applicable

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065301
Enrollment
1600
Registered
2024-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: O244- Gestational diabetes mellitus

Interventions

Intervention1: Iron and folic acid (IFA) tablet containing 30 mg elemental iron: IFA tablet containing 30 mg of elemental iron and 500 mcg folic acid to be taken orally once daily (morning) every day

Sponsors

Joe Varghese
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Primigravidae Singleton pregnancy, as a result of natural conception Gestational age: 12-16 weeks Hemoglobin level â?¥ 11 g/dL (non-anemic) Willing to come to CMC, Vellore, for regular antenatal check-up till OGTT is done (at 24-28 weeks gestation).

Exclusion criteria

Exclusion criteria: Previously diagnosed to have diabetes mellitus or found to have a fasting glucose â?¥ 92 mg/dL at first antenatal visit Any major medical illness requiring regular medication (e.g., thyroid disorders, autoimmune conditions etc.) High-risk pregnancy (as determined by the treating obstetrician)

Design outcomes

Primary

MeasureTime frame
Incidence of GDM in the 2 groups at the end of interventions, as determined by OGTT.Timepoint: At the end of intervention (12 weeks)

Secondary

MeasureTime frame
Incidence of anemia (Hb â?¤ 10.5 g/dL) in the 2 groupsTimepoint: At the end of the intervention (12 weeks);Changes in iron-related parameters (serum iron, ferritin, transferrin saturation, non-transferrin bound iron [NTBI], and sTFR)Timepoint: At the end of the intervention, compared to baseline.

Countries

India

Contacts

Public ContactJoe Varghese

Christian Medical College

joevarghese@cmcvellore.ac.in9843243682

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jul 30, 2026