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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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10 October 2016 |
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Main ID: |
NCT02922803 |
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Date of registration:
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28/09/2016 |
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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 D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
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Scientific title:
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Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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123 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02922803 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Paul Kalliokoski, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University |
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Name:
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Monica Löfvander, Ass. Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pregnant or new mother from Sweden or Somalia living in Borlänge and registered the
antenatal clinic in Borlänge maximally 21 months prior to study start.
Exclusion Criteria:
- Severe metabolic, medical or mental disease (ex. deranged type I diabetes or
psychosis).
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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Muscle Weakness
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Vitamin D Deficiency
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Intervention(s)
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Drug: 2 combination tablets of Vitamin D3/calcium per day
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Drug: 1 combination tablet of Vitamin D3/calcium per day
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Primary Outcome(s)
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Grip strength in Newton.
[Time Frame: 10 months]
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S-25-hydroxyvitamin D in nmol/L.
[Time Frame: 10 months]
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Upper leg strength, able or not able to squat
[Time Frame: 10 months]
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Secondary Outcome(s)
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Standing on one leg 30 seconds, able or not
[Time Frame: 10 months]
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Trendelenburg's sign positive or not. not.
[Time Frame: 10 months]
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Sit to stand five times, able or not.
[Time Frame: 10 months]
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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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