Clinical trial NCT02506439: Nutritional Requirements for Vitamin D in Pregnant Women
Official title: Randomized Controlled Trial to Determine the Nutritional Requirement for Vitamin D for Prevention of Deficiency During Pregnancy and in the Early Neonatal Period (D-MAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Cholecalciferol
Dose-response
Randomized Controlled Trial
Pregnancy
Cord blood
Serum 25-hydroxyvitamin D
Vitamin D Deficiency
Nutrition
Dietary intervention study
Lead sponsor: University College Cork
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2015-07-23
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum 25-hydroxyvitamin D in pregnant women and cord blood
timeFrame: Change from 1st through 2nd trimester and at delivery
Secondary outcomes:
measure: Serum total calcium
timeFrame: Change from 1st through 2nd trimester and at delivery
measure: Serum Parathyroid Hormone
timeFrame: Change from 1st through 2nd trimester and at delivery
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital and University College Cork
city: Cork
country: Ireland
facility: Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork
Study officials:
affiliation: University College Cork
name: Mairead Kiely, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.