Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

Study Overview
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Brief Summary
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The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

Detailed Description
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Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.

Official Title
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High Prevalence of Rickets and Subclinical Maternal and Childhood Vitamin D Deficiency in the Middle East: a Randomized Controlled Trial of Prenatal Vitamin D Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Prenatal Vitamin
* Drug: Cholecalciferol (Vitamin D3)
* Drug: Cholecalciferol (Vitamin D3)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are within the ages of 18-45 years In good general health 12 weeks pregnant (based on last menstrual period) Exclusion Criteria: Mothers with preexisting type I or type II diabetes Mothers with preexisting hypertension Mothers with preexisting parathyroid disease or uncontrolled thyroid disease Mothers with multiple fetuses (e.g., twins, triplets, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Prenatal Vitamin D3<br>Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D | Drug: Prenatal Vitamin<br>* Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery<br>|
| Experimental: 2<br>Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3) | Drug: Prenatal Vitamin<br>* Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery<br>Drug: Cholecalciferol (Vitamin D3)<br>* Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery<br>|
| Experimental: 3<br>Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3). | Drug: Prenatal Vitamin<br>* Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery<br>Drug: Cholecalciferol (Vitamin D3)<br>* Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal serum 25-hydroxyvitamin D measurement at 12, 16, 28 weeks during pregnancy and at delivery and cord blood or neonatal serum 25-hydroxyvitamin D measurement | 12, 16, 28 weeks and at maternal delivery and neonatal birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth | At delivery | 
| Birthweight of Newborn Infant | Growth of the Newborn Infant as Measured by Birthweight in grams. | Measured at birth. |