A Phase 3 interventional study of Euro D and Euro D in Hypovitaminosis D, Pregnancy Complications and Infant, Newborn, Diseases, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by American University of Beirut Medical Center · Phase 3, Interventional, and Treatment
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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.
Hypovitaminosis D is prevalent worldwide across the lifecycle, including pregnant women, and particularly in the Middle East. It has been associated with adverse maternal and neonatal outcomes. While the Institute of Medicine (IOM) recommends 600 IU of vitamin D per day to reach a 25-Hydroxyvitamin D (25(OH)D) level ≥ 20 ng/ml, the Endocrine Society (ES) recommends 1,500-2,000 IU/day to reach a level ≥ 30 ng/ml, and the WHO guidelines do not recommend any supplementation as part of routine prenatal care. They do however underscore the fact that subjects with the lowest levels may be the ones to benefit most from vitamin D replacement. The benefits of such an approach and the doses needed to reach desirable levels have not been tested. This randomized trial proposes to do so, testing the effect of two vitamin D doses, a low dose of 600 IU daily and a high dose of 3,000 IU daily.
330 pregnant women, with 25(OH)D level 10-30 ng/ml during the early second trimester will be recruited form the American University of Beirut-Medical Center (AUB-MC), and Bahman Hospital. They will be randomized, in a double blinded fashion, to receive daily equivalent doses of cholecalciferol, 600 IU or 3,000 IU until delivery. Maternal clinical information and a food frequency questionnaire will be obtained at each visit until delivery. Maternal 25(OH)D and chemistries, including Calcium, creatinine, lipid profile, glucose and Insulin will be assessed at study entry, during third trimester and at delivery. Fetal measurements will be collected at study entry and during the second trimester. Neonatal anthropometric variables and venous umbilical cord 25(OH)D level will be measured at birth and infants will also undergo dual-energy x-ray absorptiometry (DEXA) scan assessment, for bone and fat mass, at one to 6 weeks. Maternal and neonatal genetic studies for vitamin D genes polymorphism, and other modules of placnetal calcium transport will be also performed.
Throughout the study, adverse events will be collected systematically and an independent Data and Safety Monitoring Board will be asked to review serious adverse events.
The percent of women achieving 25(OH)D ≥ 20ng/ml in the low dose will be compared to that in the high dose using Chi-Square. Independent t-test will be used to compare mean neonatal bone mineral content at one month of age between the 2 arms. For other outcomes, t-test will be used for continuous outcomes and Chi-square will be used for binary outcomes to compare means and proportions, respectively. The primary analysis is an intention-to-treat analysis (ITT) of unadjusted results. For the primary outcomes, p- values will be considered statistically significant if ≤ 0.025.
The investigators study would be the only randomized controlled trial in the Middle East, to investigate the recommended daily allowance for vitamin D, and the desirable dose to optimize neonatal musculoskeletal health, in women with low 25(OH)D levels, levels that are reflective of those in most countries from the Middle East.
801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.
This study's planned enrollment of 330 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →American University of Beirut Medical Center is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Vitamin D3 Euro D 10,000 IU (1 tablet) plus Euro D Placebo (1 tablet) weekly, alternating with Euro D Placebo (2 tablets) weekly, starting at the second trimester and continued until delivery.
Dietary Supplement: Euro D
Vitamin D3 Euro D 10,000 IU (2 tablets, equivalent to 20,000 IU) weekly, starting at the second trimester and continued until delivery.
Dietary Supplement: Euro D
Vitamin D3 Euro D 10,000 IU (1 tablet) plus Euro D Placebo (1 tablet) weekly, alternating with Euro D Placebo (2 tablets) weekly, starting at the second trimester and continued until delivery.
Also known as: Europharm
Vitamin D3 Euro D 10,000 IU (2 tablets, equivalent to 20,000 IU) weekly, starting at the second trimester and continued until delivery.
Also known as: Europharm
The proportions of women who will reach the IOM defined desirable 25(OH)D level ≥20ng/ml.
Time frame: At delivery
Infant bone mineral content (BMC)
We will assess Infant bone mineral content (BMC) by whole body dual-energy x-ray absorptiometry (DEXA) scan
Time frame: one to six weeks
Maternal 25(OH)D level
We will assess mean maternal 25(OH)D level
Time frame: At delivery
Neonatal 25(OH)D level, at delivery
We will assess mean neonatal 25(OH)D level
Time frame: At birth
Mean infant fat mass
We will assess Infant fat mass by whole body dual-energy x-ray absorptiometry (DEXA) scan
Time frame: At one month of age
Neonatal Knee to heel length at birth
We will assess neonatal Knee to heel length at birth using simple vernier calipers
Time frame: At birth
Maternal Parathyroid Hormone (PTH) Level
We will assess mean maternal PTH level
Time frame: At delivery
Neonatal Parathyroid Hormone (PTH) Level
We will assess mean neonatal PTH level
Time frame: At birth
Mean change in maternal urine calcium
We will assess the change in urine calcium level after 3 months of vitamin D supplementation.
Time frame: Change between baseline and 3 months following intervention
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.
Time frame: At delivery
Maternal weight
Time frame: At delivery
Maternal Blood Pressure (BP)
Time frame: At delivery
Number of ill days
Time frame: At 28-32 weeks Gestational Age (GA) and at delivery
Intrauterine fetal skeletal measures
We will collect intrauterine fetal skeletal measures including crown-rump, femur length, abdominal circumference, head circumference, biparietal diameter
Time frame: At 11-13 weeks and at 20 weeks
APGAR score
Proportion of neonates with low APGAR (\<7) score at 1 and 5 minutes, at delivery
Time frame: At delivery
Neonatal weight
Time frame: At birth
Neonatal length
Time frame: At birth
Placental weight
Time frame: At delivery
Placental 1α hydroxylase activity
Time frame: At delivery
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
Time frame: At delivery
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.
Time frame: One month of age
The record gives a start of Jul 2015, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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