Nutritional Requirements for Vitamin D in Pregnant Women

Vitamin D Deficiency Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506439
• Other study ID #: ODINWP4DMAT
• Status: Completed
• Phase: N/A
• First received: May 12, 2015
• Last updated: May 2, 2017
• Start date: November 1, 2014
• Est. completion date: April 1, 2017

Study information

• Verified date: May 2017
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

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)
• 20 mcg Vitamin D3
Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
• Placebo
Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

Locations

Country	Name	City	State
Ireland	Cork University Maternity Hospital and University College Cork	Cork
Ireland	Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Mairead Kiely PhD	European Commission

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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