DMAT: Nutritional Requirements for Vitamin D in Pregnant Women

Sponsor

Mairead Kiely PhD (Other)

Overall Status

Completed

CT.gov ID

NCT02506439

Collaborator

European Commission (Other)

144

Enrollment

Locations

Arms

Actual Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency	Dietary Supplement: 10 mcg Vitamin D3 Dietary Supplement: 20 mcg Vitamin D3 Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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)

Actual Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Serum 25-hydroxyvitamin D in pregnant women and cord blood [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 Outcome Measures

Serum total calcium [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
Maternal blood pressure during pregnancy [Change from 1st through 2nd trimester and at delivery]
Blood pressure measurements will be taken in the first, second and third trimesters
Serum Parathyroid Hormone [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cork University Maternity Hospital and University College Cork	Cork		Ireland
2	Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork	Cork		Ireland