Vitamin D Deficiency
Conditions
Brief summary
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
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.
Interventions
DRUGPrenatal Vitamin
Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery
Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery
Sponsors
United Arab Emirates University
Thrasher Research Fund
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | 12, 16, 28 weeks and at maternal delivery and neonatal birth | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | At delivery | Growth of the newborn infant as measured by crown-heel length in centimeters and head circumference in centimeters at birth |
| Birthweight of Newborn Infant | Measured at birth. | Growth of the Newborn Infant as Measured by Birthweight in grams. |
Countries
United Arab Emirates, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 400 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D | 64 |
| 2000 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D | 65 |
| 4000 IU Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D | 63 |
| Total | 192 |
Baseline characteristics
| Characteristic | 400 IU | 2000 IU | 4000 IU | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 65 Participants | 63 Participants | 192 Participants |
| Age, Continuous | 27.5 years STANDARD_DEVIATION 5.5 | 27.4 years STANDARD_DEVIATION 4.8 | 25.7 years STANDARD_DEVIATION 5.5 | 26.9 years STANDARD_DEVIATION 5.3 |
| Maternal serum 25 hydroxy Vitamin D (25(OH)D) | 21.5 nmol/L STANDARD_DEVIATION 13 | 20.5 nmol/L STANDARD_DEVIATION 11.9 | 19.6 nmol/L STANDARD_DEVIATION 7.7 | 20.7 nmol/L STANDARD_DEVIATION 11.6 |
| Region of Enrollment United Arab Emirates | 64 participants | 65 participants | 63 participants | 192 participants |
| Sex: Female, Male Female | 64 Participants | 65 Participants | 63 Participants | 192 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 65 | 0 / 63 |
| serious Total, serious adverse events | 0 / 64 | 0 / 65 | 0 / 63 |
Outcome results
Primary
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
Time frame: 12, 16, 28 weeks and at maternal delivery and neonatal birth
Population: Intention to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 400 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at Delivery | 48.2 nmol/L | Standard Error 3.1 |
| 400 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 28 Weeks | 53.9 nmol/L | Standard Error 3.2 |
| 400 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 12 Weeks | 21.5 nmol/L | Standard Error 1.6 |
| 400 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 16 Weeks | 40.7 nmol/L | Standard Error 2.1 |
| 400 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Neonatal at Birth | 36.9 nmol/L | Standard Error 2.8 |
| 2000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 28 Weeks | 82.3 nmol/L | Standard Error 4.4 |
| 2000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 12 Weeks | 20.5 nmol/L | Standard Error 1.5 |
| 2000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 16 Weeks | 53.7 nmol/L | Standard Error 2.3 |
| 2000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at Delivery | 64.9 nmol/L | Standard Error 4 |
| 2000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Neonatal at Birth | 48.3 nmol/L | Standard Error 3.5 |
| 4000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Neonatal at Birth | 66.1 nmol/L | Standard Error 3.2 |
| 4000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at Delivery | 89.8 nmol/L | Standard Error 4.6 |
| 4000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 12 Weeks | 19.6 nmol/L | Standard Error 1 |
| 4000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 28 Weeks | 88.2 nmol/L | Standard Error 4.2 |
| 4000 IU | Maternal Serum and Neonatal Serum 25-hydroxyvitamin D Measurement | Maternal at 16 Weeks | 60.7 nmol/L | Standard Error 3.3 |
Secondary
Birthweight of Newborn Infant
Growth of the Newborn Infant as Measured by Birthweight in grams.
Time frame: Measured at birth.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 400 IU | Birthweight of Newborn Infant | 3100 Grams | Standard Deviation 374 |
| 2000 IU | Birthweight of Newborn Infant | 3191 Grams | Standard Deviation 492 |
| 4000 IU | Birthweight of Newborn Infant | 3103 Grams | Standard Deviation 639 |
Secondary
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
Time frame: At delivery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 400 IU | Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | Heel Crown Length | 51.9 cm | Standard Deviation 2.2 |
| 400 IU | Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | Head Circumference | 34.1 cm | Standard Deviation 1.4 |
| 2000 IU | Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | Heel Crown Length | 51.6 cm | Standard Deviation 2.8 |
| 2000 IU | Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | Head Circumference | 34.5 cm | Standard Deviation 2 |
| 4000 IU | Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | Heel Crown Length | 50.9 cm | Standard Deviation 3.7 |
| 4000 IU | Growth of the Newborn Infant as Measured by Crown-heel Length and Head Circumference at Birth | Head Circumference | 33.9 cm | Standard Deviation 2.2 |