Nutritional Requirements for Vitamin D in Pregnant Women

University College Cork144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

144

Conditions

Vitamin D Deficiency

Interventions

10 mcg Vitamin D3DIETARY_SUPPLEMENT

Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

20 mcg Vitamin D3DIETARY_SUPPLEMENT

Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

PlaceboDIETARY_SUPPLEMENT

Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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