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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 March 2023 |
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Main ID: |
NCT02434380 |
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Date of registration:
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27/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes
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Scientific title:
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Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes: a Randomized Controlled Trial in Pregnant Women With Hypovitaminosis D |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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330 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02434380 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Ghada El Hajj Fuleihan, Professor of Medicine |
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Address:
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Telephone:
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Email:
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Affiliation:
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American University of Beirut Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy Complications
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Hypovitaminosis D
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Infant, Newborn, Diseases
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Intervention(s)
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Dietary Supplement: Euro D
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Primary Outcome(s)
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Infant bone mineral content (BMC)
[Time Frame: one to six weeks]
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The proportions of women who will reach the IOM defined desirable 25(OH)D level =20ng/ml.
[Time Frame: At delivery]
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Secondary Outcome(s)
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Maternal Parathyroid Hormone (PTH) Level
[Time Frame: At delivery]
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Maternal 25(OH)D level
[Time Frame: At delivery]
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Neonatal Parathyroid Hormone (PTH) Level
[Time Frame: At birth]
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Neonatal Knee to heel length at birth
[Time Frame: At birth]
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Mean infant fat mass
[Time Frame: At one month of age]
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Neonatal 25(OH)D level, at delivery
[Time Frame: At birth]
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Mean change in maternal urine calcium
[Time Frame: Change between baseline and 3 months following intervention]
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Secondary ID(s)
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AUBMC-IM-GE-HF-22
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AUBMC-GE-HF-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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