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PREDIN: Pregnancy and Vitamin D Intervention Study

NCT05329428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-03-11

No results posted yet for this study

Summary

Vitamin D deficiency is common among certain risk groups in Sweden, and occurs approximately in every tenth pregnant woman.The aim of the randomized double-blind controlled trial Pregnancy vitamin D intervention (PREDIN) is to investigate the dose of vitamin D supplementation required in achieving vitamin D sufficiency (25OHD ≥50 nmol/l) in pregnant women at risk of vitamin D deficiency. In addition, the investigators aim to examine if the overall vitamin D status and vitamin D intake have increased since the expanded vitamin D fortification program was initiated in year 2020.

Conditions

  • Vitamin D Deficiency
  • Vitamin D3 Deficiency
  • Pregnancy Complications

Interventions

DIETARY_SUPPLEMENT

Vitamin D Supplementation 40 µg/day

At a routine visit at the antenatal care in early pregnancy (gestational week \<15) women will be provided with with vitamin D3 (cholecalciferol) supplements. Two tablets, with a total content of 40 µg (1600 IE), are taken daily throughout pregnancy.

OTHER

Usual Antenatal Care

In early pregnancy (gestational week \<15) women are advised by the regular midwife to take a daily supplement of Vitamin D throughout pregnancy, according to usual antenatal care routines.

DIETARY_SUPPLEMENT

Vitamin D Supplementation 20 µg/day

At a routine visit at the antenatal care in early pregnancy (gestational week \<15) women will be provided with with vitamin D3 (cholecalciferol) supplements. Two tablets, with a total content of 20 µg (800 IE), are taken daily throughout pregnancy.

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Göteborg University

    lead OTHER

Principal Investigators

  • Hanna Augustin, Ass Prof · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2024-07-18
Completion
2024-09-16

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329428 on ClinicalTrials.gov