Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Cholecalciferol, Dose-response, Randomized Controlled Trial, Pregnancy, Cord blood, Serum 25-hydroxyvitamin D, Vitamin D Deficiency, Nutrition, Dietary intervention study
Brief summary
Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENT10 mcg Vitamin D3
Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
DIETARY_SUPPLEMENT20 mcg Vitamin D3
Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
DIETARY_SUPPLEMENTPlacebo
Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Sponsors
European Commission
University College Cork
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult (\>18 years) * No more than 18 weeks gestation * In good general health * Low risk pregnancy * Not consuming \>10 mcg/d vitamin D from supplements
Exclusion criteria
* Current smokers * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum 25-hydroxyvitamin D in pregnant women and cord blood | Change from 1st through 2nd trimester and at delivery | Analysis of serum 25-hydroxyvitamin D in mothers for blood taken in the first, second and third trimesters and in umbilical cord |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum total calcium | Change from 1st through 2nd trimester and at delivery | Analysis of serum total calcium (adjusted for albumin) in mothers for blood taken in the first, second and third trimesters and in umbilical cord |
| Serum Parathyroid Hormone | Change from 1st through 2nd trimester and at delivery | Analysis of serum PTH in mothers for blood taken in the first, second and third trimesters and in umbilical cord |
Countries
Ireland
Outcome results
None listed