Low-dose calcium in pregnancy (India)
Trial question
Is low-dose calcium supplementation noninferior to high-dose calcium supplementation in pregnant women?
Study design
Multi-center
Double blinded
RCT
Population
11000 female patients.
Inclusion criteria: adult nulliparous pregnant women.
Key exclusion criteria: history, signs, or symptoms of nephrolithiasis; history of parathyroid disorder or thyroidectomy; disease for which digoxin, phenytoin, or tetracycline is indicated.
Interventions
N=5497 low-dose calcium (at a daily dose of 500 mg).
N=5503 high-dose calcium (at a daily dose of 1,500 mg).
Primary outcome
Preeclampsia
3%
3.6%
3.6 %
2.7 %
1.8 %
0.9 %
0.0 %
Low-dose
calcium
High-dose
calcium
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in preeclampsia (3% vs. 3.6%; RR 0.84, 95% CI 0.68 to 1.03).
Secondary outcomes
Borderline significant decrease in preterm birth (11.4% vs. 12.8%; RR 0.89, 95% CI 0.8 to 0.98).
No significant difference in gestational hypertension (3.2% vs. 3.8%; RR 0.85, 95% CI 0.7 to 1.03).
Borderline significant decrease in preeclampsia with severe features (1.1% vs. 1.8%; RR 0.63, 95% CI 0.46 to 0.87).
Safety outcomes
No significant difference in maternal hospitalization or maternal third-trimester severe anemia.
Conclusion
In adult nulliparous pregnant women, low-dose calcium was noninferior to high-dose calcium with respect to preeclampsia.
Reference
Pratibha Dwarkanath, Alfa Muhihi, Christopher R Sudfeld et al. Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy. N Engl J Med. 2024 Jan 11;390(2):143-153.
Open reference URL