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Completed

NCT Number: NCT02506439

Nutritional Requirements for Vitamin D in Pregnant Women

Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cork University Maternity Hospital and University College Cork, Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 mcg Vitamin D3

Dietary Supplement

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

Other names: Cholecalciferol

20 mcg Vitamin D3

Dietary Supplement

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

Other names: Cholecalciferol

Placebo

Dietary Supplement

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

Other names: Placebo capsule

Primary outcomes

  1. Serum 25-hydroxyvitamin D in pregnant women and cord blood

    Time frame: 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 outcomes

  1. Serum total calcium

    Time frame: 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

  2. Serum Parathyroid Hormone

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

  • European Commission

Registry information

Official study 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)

Acronym: DMAT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 23, 2015
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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