Pregnancy Complications Clinical Trial
Official title:
Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes: a Randomized Controlled Trial in Pregnant Women With Hypovitaminosis D
Verified date | March 2023 |
Source | American University of Beirut Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The optimal vitamin D replacement dose during pregnancy remains undefined. Therefore, the aim of this study is to test the hypothesis that a daily equivalent dose of vitamin D of 3,000 IU/day is needed for Middle Eastern women, to optimize maternal vitamin D level and neonatal musculoskeletal parameters, specifically knee-heel length at birth and bone mineral content at one month of age.
Status | Completed |
Enrollment | 330 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Pregnant women gestational age (GA)< 14 weeks at screening visit. Middle Eastern woman (Middle East countries defined by WHO: Bahrain, Egypt, Iran, Iraq, Palestine, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, , United Arab Emirates, Yemen) - 25(OH)D level between 10ng/ml and 30ng/ml - Age > 18 years - Vitamin D supplementation = 200 IU daily (If daily vitamin D supplementation > 200 IU daily, at enrollment, the pregnant women will be advised to adjust prenatal multivitamin doses in such a way that total vitamin D supplementation per week doesn't exceed 1400 IU per week, in consultation with primary Obstetric and Gynecology (OB-GYN) physician.) Exclusion Criteria: - 25(OH)D level < 10 ng/ml or > 30 ng/ml. - Known metabolic bone disease - Current medications likely to interfere with vitamin D metabolism (enzyme inducing anticonvulsants, anti -TB) - Vitamin D supplementation > 600 IU daily - Pregnant women with twins |
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut | Hamra |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center | Bahman Hospital Beirut Lebanon, University of Southampton |
Lebanon,
Al-Shaar L, Mneimneh R, Nabulsi, Maalouf J, Fuleihan Gel-H. Vitamin D3 dose requirement to raise 25-hydroxyvitamin D to desirable levels in adolescents: results from a randomized controlled trial. J Bone Miner Res. 2014 Apr;29(4):944-51. doi: 10.1002/jbmr.2111. — View Citation
Arabi A, El Rassi R, El-Hajj Fuleihan G. Hypovitaminosis D in developing countries-prevalence, risk factors and outcomes. Nat Rev Endocrinol. 2010 Oct;6(10):550-61. doi: 10.1038/nrendo.2010.146. — View Citation
Bassil D, Rahme M, Hoteit M, Fuleihan Gel-H. Hypovitaminosis D in the Middle East and North Africa: Prevalence, risk factors and impact on outcomes. Dermatoendocrinol. 2013 Apr 1;5(2):274-98. doi: 10.4161/derm.25111. — View Citation
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El-Hajj Fuleihan G, Nabulsi M, Tamim H, Maalouf J, Salamoun M, Khalife H, Choucair M, Arabi A, Vieth R. Effect of vitamin D replacement on musculoskeletal parameters in school children: a randomized controlled trial. J Clin Endocrinol Metab. 2006 Feb;91(2):405-12. doi: 10.1210/jc.2005-1436. Epub 2005 Nov 8. — View Citation
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Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908. — View Citation
Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL. Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness. J Bone Miner Res. 2011 Oct;26(10):2341-57. doi: 10.1002/jbmr.463. Erratum In: J Bone Miner Res. 2011 Dec; 26(12):3001. — View Citation
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Thorne-Lyman A, Fawzi WW. Vitamin D during pregnancy and maternal, neonatal and infant health outcomes: a systematic review and meta-analysis. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1(0 1):75-90. doi: 10.1111/j.1365-3016.2012.01283.x. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Composite outcome (incidence of C-section and gestational diabetes mellitus (GDM)) | We will assess the incidence of a composite outcome (C-section and gestational diabetes mellitus (GDM)) in a subgroup of women who has no previous C-section. | At delivery | |
Other | Maternal weight | At delivery | ||
Other | Maternal Blood Pressure (BP) | At delivery | ||
Other | Number of ill days | At 28-32 weeks Gestational Age (GA) and at delivery | ||
Other | Intrauterine fetal skeletal measures | We will collect intrauterine fetal skeletal measures including crown-rump, femur length, abdominal circumference, head circumference, biparietal diameter | At 11-13 weeks and at 20 weeks | |
Other | APGAR score | Proportion of neonates with low APGAR (<7) score at 1 and 5 minutes, at delivery | At delivery | |
Other | Neonatal weight | At birth | ||
Other | Neonatal length | At birth | ||
Other | Placental weight | At delivery | ||
Other | Placental 1a hydroxylase activity | At delivery | ||
Other | Sub-group analysis: The proportions of women who will reach the IOM defined desirable 25(OH)D level =20ng/ml. | Subgroup analysis based on baseline 25(OH)D, less than 20 ng/ml versus less than 30 ng/ml and season of birth will be performed | At delivery | |
Other | Sub-group analysis:Infant bone mineral content (BMC) | Subgroup analysis based on baseline 25(OH)D, less than 20 ng/ml versus less than 30 ng/ml and season of birth will be performed. | One month of age | |
Primary | The proportions of women who will reach the IOM defined desirable 25(OH)D level =20ng/ml. | At delivery | ||
Primary | Infant bone mineral content (BMC) | We will assess Infant bone mineral content (BMC) by whole body dual-energy x-ray absorptiometry (DEXA) scan | one to six weeks | |
Secondary | Maternal 25(OH)D level | We will assess mean maternal 25(OH)D level | At delivery | |
Secondary | Neonatal 25(OH)D level, at delivery | We will assess mean neonatal 25(OH)D level | At birth | |
Secondary | Mean infant fat mass | We will assess Infant fat mass by whole body dual-energy x-ray absorptiometry (DEXA) scan | At one month of age | |
Secondary | Neonatal Knee to heel length at birth | We will assess neonatal Knee to heel length at birth using simple vernier calipers | At birth | |
Secondary | Maternal Parathyroid Hormone (PTH) Level | We will assess mean maternal PTH level | At delivery | |
Secondary | Neonatal Parathyroid Hormone (PTH) Level | We will assess mean neonatal PTH level | At birth | |
Secondary | Mean change in maternal urine calcium | We will assess the change in urine calcium level after 3 months of vitamin D supplementation. | Change between baseline and 3 months following intervention |
Status | Clinical Trial | Phase | |
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