Nutritional Requirements for Vitamin D in Pregnant Women (DMAT)

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)

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: 10 mcg Vitamin D3; Dietary supplement: 20 mcg Vitamin D3; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Cork University Maternity Hospital and University College Cork
  • Cork, Ireland
    • Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mcg Vitamin D3; White-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg [400 IU] daily	Dietary supplement: 10 mcg Vitamin D3; Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery); Other Names: Cholecalciferol
Experimental: 20 mcg Vitamin D3; White-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg [800 IU] daily	Dietary supplement: 20 mcg Vitamin D3; Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery); Other Names: Cholecalciferol
Placebo Comparator: Placebo; White-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product	Dietary supplement: Placebo; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from 1st through 2nd trimester and at delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from 1st through 2nd trimester and at delivery
Maternal blood pressure during pregnancy	Blood pressure measurements will be taken in the first, second and third trimesters	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	Change from 1st through 2nd trimester and at delivery

Collaborators and Investigators

• Sponsor: Mairead Kiely PhD
• Collaborators: European Commission
• Investigators: Principal Investigator: Mairead Kiely, PhD, University College Cork

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin D; Pregnancy; Nutrition; Randomized Controlled Trial; Cholecalciferol; Dose-response; Cord blood; Serum 25-hydroxyvitamin D; Vitamin D Deficiency; Dietary intervention study
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: ODINWP4DMAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: IPD may be considered, for vitamin D intake and 25(OH)D data. Please contact m.kiely@ucc.ie.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No