An interventional study of 10 mcg Vitamin D3 and 20 mcg Vitamin D3 in Vitamin D Deficiency, sponsored by University College Cork. Completed at 2 sites in Ireland. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by University College Cork · Not applicable, Interventional, and Prevention
Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.
This is a three-arm, parallel, double-blind, placebo-controlled dose-response intervention study with vitamin D3. Women will be recruited prior to 18 weeks of gestation and randomised to receive placebo, 10 or 20 mcg/d of vitamin D3 from baseline visit in their first trimester until delivery. Blood samples will be collected at baseline, midpoint and endpoint of the trial, at 10 week intervals, and from the umbilical cord at delivery. A 25-hydroxyvitamin D concentration of 30 nmol/L will be used to denote vitamin D deficiency. Information on maternal anthropometry, diet, lifestyle, sun exposure, blood pressure, iPTH and serum total calcium will also be reported.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 144 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
White-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg \[400 IU\] daily
Dietary Supplement: 10 mcg Vitamin D3
White-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg \[800 IU\] daily
Dietary Supplement: 20 mcg Vitamin D3
White-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product
Dietary Supplement: Placebo
Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Also known as: Cholecalciferol
Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Also known as: Cholecalciferol
Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Also known as: Placebo capsule
Serum 25-hydroxyvitamin D in pregnant women and cord blood
Analysis of serum 25-hydroxyvitamin D in mothers for blood taken in the first, second and third trimesters and in umbilical cord
Time frame: Change from 1st through 2nd trimester and at delivery
Serum total calcium
Analysis of serum total calcium (adjusted for albumin) in mothers for blood taken in the first, second and third trimesters and in umbilical cord
Time frame: Change from 1st through 2nd trimester and at delivery
Serum Parathyroid Hormone
Analysis of serum PTH in mothers for blood taken in the first, second and third trimesters and in umbilical cord
Time frame: Change from 1st through 2nd trimester and at delivery
Plan to share: Undecided — IPD may be considered, for vitamin D intake and 25(OH)D data. Please contact m.kiely@ucc.ie.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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University College Cork