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Nutritional Requirements for Vitamin D in Pregnant Women (DMAT)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
10 mcg Vitamin D3
20 mcg Vitamin D3
Placebo
Sponsored by
Mairead Kiely PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, Cholecalciferol, Dose-response, Randomized Controlled Trial, Pregnancy, Cord blood, Serum 25-hydroxyvitamin D, Vitamin D Deficiency, Nutrition, Dietary intervention study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

10 mcg Vitamin D3

20 mcg Vitamin D3

Placebo

Arm Description

White-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg [400 IU] daily

White-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg [800 IU] daily

White-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Maternal blood pressure during pregnancy
Blood pressure measurements will be taken in the first, second and third trimesters
Serum Parathyroid Hormone
Analysis of serum PTH in mothers for blood taken in the first, second and third trimesters and in umbilical cord

Full Information

First Posted
May 12, 2015
Last Updated
May 2, 2017
Sponsor
Mairead Kiely PhD
Collaborators
European Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02506439
Brief Title
Nutritional Requirements for Vitamin D in Pregnant Women
Acronym
DMAT
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mairead Kiely PhD
Collaborators
European Commission

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mcg Vitamin D3
Arm Type
Experimental
Arm Description
White-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg [400 IU] daily
Arm Title
20 mcg Vitamin D3
Arm Type
Experimental
Arm Description
White-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg [800 IU] daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
White-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product
Intervention Type
Dietary Supplement
Intervention Name(s)
10 mcg Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Intervention Type
Dietary Supplement
Intervention Name(s)
20 mcg Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo capsule
Intervention Description
Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
Primary Outcome Measure Information:
Title
Serum 25-hydroxyvitamin D in pregnant women and cord blood
Description
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 Outcome Measure Information:
Title
Serum total calcium
Description
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
Title
Maternal blood pressure during pregnancy
Description
Blood pressure measurements will be taken in the first, second and third trimesters
Time Frame
Change from 1st through 2nd trimester and at delivery
Title
Serum Parathyroid Hormone
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mairead Kiely, PhD
Organizational Affiliation
University College Cork
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cork University Maternity Hospital and University College Cork
City
Cork
Country
Ireland
Facility Name
Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork
City
Cork
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD may be considered, for vitamin D intake and 25(OH)D data. Please contact m.kiely@ucc.ie.
Citations:
PubMed Identifier
29878035
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.
Results Reference
derived

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Nutritional Requirements for Vitamin D in Pregnant Women

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