Nutritional Requirements for Vitamin D in Pregnant Women

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: 10 mcg Vitamin D3
* Dietary Supplement: 20 mcg Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mcg Vitamin D3<br>White-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg [400 IU] daily | Dietary Supplement: 10 mcg Vitamin D3<br>* Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)<br>* Other names: Cholecalciferol;|
| Experimental: 20 mcg Vitamin D3<br>White-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg [800 IU] daily | Dietary Supplement: 20 mcg Vitamin D3<br>* Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)<br>* Other names: Cholecalciferol;|
| Placebo Comparator: Placebo<br>White-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product | Dietary Supplement: Placebo<br>* Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)<br>* Other names: Placebo capsule;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Cholecalciferol, Dose-response, Randomized Controlled Trial, Pregnancy, Cord blood, Serum 25-hydroxyvitamin D, Vitamin D Deficiency, Nutrition, Dietary intervention study