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| Name | Class |
|---|---|
| United Arab Emirates University | OTHER |
| Thrasher Research Fund | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prenatal Vitamin D3 | Placebo Comparator | Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a placebo tablet containing 0IU of Vitamin D |
|
| 2 | Experimental | Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3)along with a tablet containing 1600IU of Cholecalciferol (Vitamin D3) |
|
| 3 | Experimental | Arm will receive prenatal vitamin with 400IU of cholecalciferol (Vitamin D3) along with a tablet containing 3600IU of Cholecalciferol (Vitamin D3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prenatal Vitamin | Drug | Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adekunle Dawodu, MBBS | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Hussein F Saadi, MD | United Arab Emirates University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States | ||
| United Arab Emirated Unitersity |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16027707 | Background | Dawodu A, Agarwal M, Sankarankutty M, Hardy D, Kochiyil J, Badrinath P. Higher prevalence of vitamin D deficiency in mothers of rachitic than nonrachitic children. J Pediatr. 2005 Jul;147(1):109-11. doi: 10.1016/j.jpeds.2005.03.001. | |
| 12584539 | Background | Dawodu A, Agarwal M, Hossain M, Kochiyil J, Zayed R. Hypovitaminosis D and vitamin D deficiency in exclusively breast-feeding infants and their mothers in summer: a justification for vitamin D supplementation of breast-feeding infants. J Pediatr. 2003 Feb;142(2):169-73. doi: 10.1067/mpd.2003.63. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 400 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D |
| FG001 | 2000 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cholecalciferol (Vitamin D3) | Drug | Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery |
|
| Cholecalciferol (Vitamin D3) | Drug | Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery |
|
Growth of the Newborn Infant as Measured by Birthweight in grams. |
| Measured at birth. |
| Al Ain City |
| Abu Dhabi Emirate |
| United Arab Emirates |
| 17556694 | Background | Saadi HF, Dawodu A, Afandi BO, Zayed R, Benedict S, Nagelkerke N. Efficacy of daily and monthly high-dose calciferol in vitamin D-deficient nulliparous and lactating women. Am J Clin Nutr. 2007 Jun;85(6):1565-71. doi: 10.1093/ajcn/85.6.1565. |
| 17715433 | Background | Dawodu A, Wagner CL. Mother-child vitamin D deficiency: an international perspective. Arch Dis Child. 2007 Sep;92(9):737-40. doi: 10.1136/adc.2007.122689. |
| 22666547 | Background | Wagner CL, Taylor SN, Dawodu A, Johnson DD, Hollis BW. Vitamin D and its role during pregnancy in attaining optimal health of mother and fetus. Nutrients. 2012 Mar;4(3):208-30. doi: 10.3390/nu4030208. Epub 2012 Mar 21. |
| 22585912 | Background | Dawodu A, Tsang RC. Maternal vitamin D status: effect on milk vitamin D content and vitamin D status of breastfeeding infants. Adv Nutr. 2012 May 1;3(3):353-61. doi: 10.3945/an.111.000950. |
| 22525442 | Background | Dawodu A, Wagner CL. Prevention of vitamin D deficiency in mothers and infants worldwide - a paradigm shift. Paediatr Int Child Health. 2012 Feb;32(1):3-13. doi: 10.1179/1465328111Y.0000000024. |
| 39077939 | Derived | Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5. |
| 23559082 | Derived | Dawodu A, Saadi HF, Bekdache G, Javed Y, Altaye M, Hollis BW. Randomized controlled trial (RCT) of vitamin D supplementation in pregnancy in a population with endemic vitamin D deficiency. J Clin Endocrinol Metab. 2013 Jun;98(6):2337-46. doi: 10.1210/jc.2013-1154. Epub 2013 Apr 4. |
| FG002 | 4000 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 400 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D |
| BG001 | 2000 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D |
| BG002 | 4000 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Maternal serum 25 hydroxy Vitamin D (25(OH)D) | Mean | Standard Deviation | nmol/L |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Intention to treat analysis. | Posted | Mean | Standard Error | nmol/L | 12, 16, 28 weeks and at maternal delivery and neonatal birth |
|
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| ||||||||||||||||||||||||||||||||
| 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 | Posted | Mean | Standard Deviation | cm | At delivery |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Birthweight of Newborn Infant | Growth of the Newborn Infant as Measured by Birthweight in grams. | Posted | Mean | Standard Deviation | Grams | Measured at birth. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 400 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D | 0 | 64 | 0 | 64 | ||
| EG001 | 2000 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D | 0 | 65 | 0 | 65 | ||
| EG002 | 4000 IU | Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D | 0 | 63 | 0 | 63 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adekunle Dawodu | Cincinnati Children's Hospital Medical Center | 513-636-1966 | Adekunle.Dawodu@cchmc.org |
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011295 | Prenatal Care |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D008427 | Maternal Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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| Between 18 and 65 years |
|
| >=65 years |
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| Male |
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| Maternal at 28 Weeks |
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| Maternal at Delivery |
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| Neonatal at Birth |
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