Vitamin D supplements during pregnancy

Oral Vitamin D supplementation as a safe, affordable treatment for profound vitamin D deficiency in pregnancy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039091

Enrollment

200

Registered

2022-01-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

None listed

Interventions

Intervention1: Experimental: Daily 2000 IU Vitamin D3: In this arm, pregnant women with vitamin D deficiency will be counselled to take two tablets daily (each containing 1000 IU vitamin D3 and 500mg

Eligibility

Inclusion criteria

Inclusion criteria: Apparent healthy pregnant woman (18-40 years), before 13 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, or consuming multi-vitamins, 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 perform an open label study of 2000IU vitamin D3/d supplementation from second trimester of pregnancy until delivery to determine whether this supplemental dose results in vitamin D repletion after interventionTimepoint: Assessment of Total Vitamin D, PTH levels in maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation). from second trimester of pregnancy until delivery to determine whether this supplemental dose results in vitamin D repletion after intervention	—

Measure

Time frame

To perform an open label study of 2000IU vitamin D3/d supplementation from second trimester of pregnancy until delivery to determine whether this supplemental dose results in vitamin D repletion after interventionTimepoint: Assessment of Total Vitamin D, PTH levels in maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation). from second trimester of pregnancy until delivery to determine whether this supplemental dose results in vitamin D repletion after intervention

—

Secondary

Measure	Time frame
To evaluate the innate immunity in the newborn of the mothers supplemented with 2000IU vitamin D3 during pregnancy Â· To archive maternal blood and cord blood for future studies on the impact of maternal genotype (VDR, VDBP) on efficacy of repletion. Â· To build a cross-disciplinary consortium of healthcare professionals, scientists, clinicians, and policy makers/regulatory authorities along with international experts and host a workshop in Bangalore, India with a definitive scholarly peer-reviewed output of wider benefit nationally and internationally, to inform the future direction of vitamin D studies across India.Timepoint: Cord blood collection during delivery Maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation) and cord blood at delivery Workshop to be hosted in May/June 2022 and proceedings to be published in July/August 2022.	—

Measure

Time frame

To evaluate the innate immunity in the newborn of the mothers supplemented with 2000IU vitamin D3 during pregnancy Â· To archive maternal blood and cord blood for future studies on the impact of maternal genotype (VDR, VDBP) on efficacy of repletion. Â· To build a cross-disciplinary consortium of healthcare professionals, scientists, clinicians, and policy makers/regulatory authorities along with international experts and host a workshop in Bangalore, India with a definitive scholarly peer-reviewed output of wider benefit nationally and internationally, to inform the future direction of vitamin D studies across India.Timepoint: Cord blood collection during delivery Maternal venous blood during pregnancy (14, 24 and 34 weeks of gestation) and cord blood at delivery Workshop to be hosted in May/June 2022 and proceedings to be published in July/August 2022.

—

Countries

India

Contacts

Public ContactDr Pratibha Dwarkanath

St Johnâ??s Research Institute

pratibha@sjri.res.in9880714118

Outcome results