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Does Vitamin D supplementation in pregnancy improves maternal and neonatal outcome?

The effect of Vitamin D supplementation in pregnancy on maternal and neonatal outcome: A double blind randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/07/006039
Enrollment
484
Registered
2015-07-21
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

None listed

Interventions

Intervention1: Cholecalciferol granules: Each satchet containing 60,000 IU of cholecalciferol orally , 1 per week for 6 weeks and then 1 monthly for 4 months Control Intervention1: Placebo: One satche

Sponsors

UCMS and GTB Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Primigravida at 16-24 weeks of gestation (by L.M.P. Method)at the time of enrollment

Exclusion criteria

Exclusion criteria: 1. Age 30 yrs 2. Multiple pregnancy 3. Extreme malnutrition (BMI >35 & 4. Patients having B.P. Systolic >130 or Diastolic >90 mmHg 5. Patients presenting with preeclampsia,antepartum haemorrhage 6. History of past chronic medical illnesses & drug history

Design outcomes

Primary

MeasureTime frame
Comparison between the groups for the incidences of I) Adverse maternal outcomes: - Gestational Hypertension - Preeclampsia - Spontaneous preterm rupture of membranes II) Adverse neonatal outcomes: - Preterm birth - Small for gestational age newborn III) 25(OH) D levels of those who develop complications to those who do not develop complications Timepoint: at the time of delivery

Secondary

MeasureTime frame
(a) Reduction in incidence of 1 - Maternal deaths 2- Maternal admissions to ICU 3 - Still Birth 4 - Early neonatal deaths ( 7days ) (b) Improvement in 1 - Apgar score at 1 min and 5 min of birth Timepoint: within 7 days of delivery

Countries

India

Contacts

Public ContactDr Pankila Mittal

UCMS & GTB Hospital

drhimsweta@yahoo.co.in9999249206

Outcome results

None listed

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