Nutritional Requirements for Vitamin D in Pregnant Women (DMAT)

University College Cork (UCC)

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: 20 mcg Vitamin D3; Dietary Supplement: 10 mcg Vitamin D3; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02506439

ODINWP4DMAT

Details and patient eligibility

About

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

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 3 patient groups, including a placebo group

10 mcg Vitamin D3

Experimental group

Description:

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

Treatment:

Dietary Supplement: 10 mcg Vitamin D3

20 mcg Vitamin D3

Experimental group

Description:

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

Treatment:

Dietary Supplement: 20 mcg Vitamin D3

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo