Impact of vitamin D supplementation of preterm births

Impact of vitamin D supplementation on preterm births and pre-rupture of membrane: A double-blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037658

Enrollment

902

Registered

2021-10-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

None listed

Interventions

Intervention1: Active Comparator: Daily 500 IU Vitamin D3 tablets (Standard dose: Pregnant woman in this arm will be provided and counselled to take two tablets each containing 250 IU vitamin D3 and 5

Eligibility

Inclusion criteria

Inclusion criteria: Apparent healthy pregnant woman (18-40 years), between 14-18 weeks of gestation, willing to give informed consent, oblige to protocol regime, consume assigned supplement, and give blood samples.

Exclusion criteria

Exclusion criteria: Pregnant women with twins or multiple pregnancies, chronic morbidities, on medication or undergoing treatment, have infections such as HIV, VDRL, HBsAg, assisted pregnancy, or anticipate discontinuing or moving out of the study site.

Design outcomes

Primary

Measure	Time frame
To evaluate whether the daily supplement of an effective dose of 2000 IU vitamin D3/d reduces the incidence of preterm births and PROM as compared to the pregnant women supplemented with the standard care of 500 IU vitamin D3/d.Timepoint: Preterm births and Pre rupture of membrane will be assessed at the time of delivery	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Pratibha Dwarkanath

St Johns Research Institute

pratibha@sjri.res.in9880714118

Outcome results