Vitamin D Supplementation During Pregnancy and Bone Status in Children at Birth and at One Year of Age

Study Overview
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Brief Summary
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Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels. We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on. The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.

Detailed Description
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This is a prospective randomized controlled study. 120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery. 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery. 25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age. Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings. Quantitative ultrasound (QUS) measurement of tibia and radius will be performed to newborns and at the age of one year. Bone status of newborns at birth and at one year age in children will be compared between the 2 groups.

Official Title
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The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pregnant women aged 20 to 40 years, of any parity status. Signed informed consent Exclusion Criteria: Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Larger doses of vitamin D supplementation<br>The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day | Dietary Supplement: Vitamin D<br>* Vitamin D 2000iu/ day from the 27 week of pregnancy up to delivery<br>|
| No Intervention: Conventional vitamin D supplementation<br>Regular supplementation during pregnancy with 400IU vitamin D | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS). |  | Bone status in offsprings, assessed at the age of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D status of mothers. |  | At the start of intervention, at delivery and at the age of one year | 
| Maternal health status. |  | At the start of intervention, at delivery and at the age of one year | 
| Infants' growth. |  | At the start of intervention, at delivery and at the age of one year | 
| Vitamin D status in infants. |  | At the start of intervention, at delivery and at the age of one year | 
| Safety of vitamin D supplementation doses. |  | At the start of intervention, at delivery and at the age of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, pregnancy, children, bone, quantitative ultrasound, Healthy pregnant women