Nutritional Requirements for Vitamin D in Pregnant Women
NCT ID: NCT02506439
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2014-11-01
2017-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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10 mcg Vitamin D3
White-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg \[400 IU\] daily
10 mcg Vitamin D3
Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
20 mcg Vitamin D3
White-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg \[800 IU\] daily
20 mcg Vitamin D3
Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Placebo
White-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product
Placebo
Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Interventions
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10 mcg Vitamin D3
Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
20 mcg Vitamin D3
Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Placebo
Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No more than 18 weeks gestation
* In good general health
* Low risk pregnancy
* Not consuming \>10 mcg/d vitamin D from supplements
Exclusion Criteria
* Diagnosed hypertension
* Known high-risk pregnancy
* Diagnosed medical illness including diabetes mellitus (Types 1 \& 2), chronic kidney disease or gastro-intestinal diseases or any illness known to interfere with calcium metabolism (e.g. sarcoidosis).
* Consumption of medications known to interfere with vitamin D metabolism
* Consumption of vitamin D (≥ 10 µg/day) or calcium (≥ 650 mg/d) supplements prior to randomization
18 Years
FEMALE
Yes
Sponsors
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European Commission
OTHER
University College Cork
OTHER
Responsible Party
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Mairead Kiely PhD
Professor of Human Nutrition
Principal Investigators
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Mairead Kiely, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Cork
Locations
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Cork University Maternity Hospital and University College Cork
Cork, , Ireland
Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork
Cork, , Ireland
Countries
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References
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Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
O'Callaghan KM, Hennessy A, Hull GLJ, Healy K, Ritz C, Kenny LC, Cashman KD, Kiely ME. Estimation of the maternal vitamin D intake that maintains circulating 25-hydroxyvitamin D in late gestation at a concentration sufficient to keep umbilical cord sera >/=25-30 nmol/L: a dose-response, double-blind, randomized placebo-controlled trial in pregnant women at northern latitude. Am J Clin Nutr. 2018 Jul 1;108(1):77-91. doi: 10.1093/ajcn/nqy064.
Other Identifiers
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ODINWP4DMAT
Identifier Type: -
Identifier Source: org_study_id
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