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Vitamin D Supplementation in Pregnancy

NCT04591847Phase 3

Key facts

Status: Completed
Start: Oct 2020
Primary completion: Jul 2021
Countries: 1
Sponsor: Ministry of Public Health
Modality: Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: vitamin d
Conditions: preeclampsiapreterm birthVitamin D deficiency (VDD)

Overview

Phase 3, randomised, double-blind trial in preeclampsia, preterm birth and Vitamin D deficiency (VDD) comparing Vitamin D Supplemented with Placebo (2 arms). Primary endpoints: Serum 25-OH vitamin D level in pregnant women and Serum 25-OH vitamin D level in umbilical cord blood. Started Oct 2020; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Vitamin D Supplemented
Vitamin D2 20,000 IU weekly
Placebo
Placebo weekly

Who it enrols

Pregnant Thai women aged 18 or older with a singleton pregnancy at 18-22 weeks gestation, excluding those with abnormal kidney function, use of antiepileptics or vitamin D supplements, allergy to vitamin D, or diagnosed vitamin D deficiency.

Endpoints

Primary

Serum 25-OH vitamin D level in pregnant womenAt delivery
Serum 25-OH vitamin D level in umbilical cord bloodAt delivery

Secondary

Preeclampsia rateDuring pregnancy until delivery
Preterm birth rateAt delivery
Infant APGAR scoreAt delivery
Infant birth weightAt delivery
Infant lengthAt delivery

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