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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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16 December 2017 |
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Main ID: |
NCT03310307 |
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Date of registration:
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11/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women
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Scientific title:
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Vitamin D3 Treatment Decreases Serum Total Homocysteine Concentrations of Overweight Reproductive Women: Randomized Placebo Controlled Clinical Trail |
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Date of first enrolment:
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April 1, 2016 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03310307 |
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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.
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Phase:
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Phase 2
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Countries of recruitment
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Jordan
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Contacts
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Name:
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Nahla S Al-Bayyari, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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BAU |
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Name:
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Jehan M Hamadneh, FRCOG |
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Address:
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Telephone:
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Email:
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Affiliation:
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JUST |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Overweight (BMI between 25-29.99 kg/m2)
- Had 25(OH)D < 20 ng/mL
- Had normal vitamin B-12 and folic acid levels
- Not diagnosed with any chronic diseases
- Agreed to participat in the study
Exclusion Criteria:
- age < 18 or > 49 years
- BMI > 30 kg/m2 or < 25 kg/m2
- 25 (OH)D level > 20 ng/ml
- tHcy levels greater than 100 µmol/L
- Abnormal vitamin B-12 or folic acid levels
- Chronic diseases
- Pregnant or lactating
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Homocystinaemia
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Vitamin D Deficiency
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Intervention(s)
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Drug: Vit D
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Other: Placebo
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Primary Outcome(s)
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25(OH)D3
[Time Frame: 2 months]
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Secondary Outcome(s)
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Homocysteine
[Time Frame: 2 months]
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Secondary ID(s)
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Hcy-VitD-01
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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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