Effect of iron supplementation on the development of diabetes mellitus during pregnancy
Phase 2
- Conditions
- Health Condition 1: O244- Gestational diabetes mellitus
- Registration Number
- CTRI/2024/04/065301
- Lead Sponsor
- Joe Varghese
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Primigravidae
Singleton pregnancy, as a result of natural conception
Gestational age: 12-16 weeks
Hemoglobin level = 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
Previously diagnosed to have diabetes mellitus or found to have a fasting glucose = 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.;Incidence of anemia (Hb = 10.5 g/dL) in the 2 groupsTimepoint: At the end of the intervention (12 weeks)