Next-generation Effects of Vitamin D Supplementation in Pregnancy
1 other identifier
observational
600
0 countries
N/A
Brief Summary
Vitamin D deficiency is common among pregnant women, despite daily vitamin D supplements. This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Blood samples at birth and after one year, questionnaires and clinical 1-year examination will be performed on the children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 7, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedNovember 15, 2022
October 1, 2022
2 years
November 7, 2022
November 7, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Growth of child
The growth from birth to the clinical examination at 11-13 month of age
From birth to 11-13 month of age
Immune cell function
The immune cell function at birth and at 11-13 month of age.
From birth to 11-13 month of age
Secondary Outcomes (6)
Well-being and developmental scores
At birth and at 11-13 month of age
Hospital contact
At birth to 11-13 month of age
Parent reported infections
At birth to 11-13 month of age
Colic
At birth to 11-13 month of age
Medicine use
At birth to 11-13 month of age
- +1 more secondary outcomes
Study Arms (2)
High-dose intrauterine D3-vitamin
Children of mothers who received 90 µg vitamin D3 daily during pregnancy from 12 weeks to delivery.
Low-dose intrauterine D3-vitamin
Children of mothers who received 10 µg vitamin D3 daily during pregnancy from 12 weeks to delivery
Interventions
Children of mothers who received 90 µg vitamin D3 daily during pregnancy:10 µg from a standard prenatal multivitamin + an additional supplement containing 80µg of vitamin D3
Children of mothers who received 10 µg vitamin D3 daily during pregnancy, which is the dose in a standard prenatal multivitamin and the dose currently recommended by the Danish Health Authorities to all pregnant women. They will receive a prenatal vitamin containing 10µg of vitamin D + a placebo supplement.
Eligibility Criteria
Children born to mothers participated in our previous RCT (NCT04291313)
You may qualify if:
- Born by mother from our previous RCT (NCT04291313)
You may not qualify if:
- Mother with compliance \<80% to study drug
- Mother has denied further contact in this follow-up study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
We are collecting bloodsamples at birth and after one year. Further we collect meconium-samples at birth
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pinar Bor, MD, PhD
Department of Obstetrics and Gynaecology, Regional Hospital Randers
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2022
First Posted
November 15, 2022
Study Start
November 1, 2022
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
November 15, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share