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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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3 August 2015 |
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Main ID: |
NCT02212223 |
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Date of registration:
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06/08/2014 |
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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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Marwo-D Research -Need for Vitamin D in Different Population Groups
ODIN |
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Scientific title:
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Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN) |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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147 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02212223 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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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Finland
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Contacts
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Name:
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Christel Lamberg-Allardt, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Helsinki University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- woman between 21-66 years of age
- belongs to original Finnish population or to Somali immigrant population
- healthy (= no disease requiring medication)
- lives in the metropolitan area
Exclusion Criteria:
- pregnant or breastfeeding
- has traveled to a sunny destination or destination near the equator during the
previous month
- plans to travel to a sunny destination or destination near the equator in the next 6
months
- has used a tanning bed during the previous month
- plans to use a tanning bed in the next 6 months
- the subject's blood 25-hydroxy-vitamin D level (25 (OH) D), exceeds 100 nmol / L or
is less than 30 nmol / L at baseline in the screening phase.
Age minimum:
21 Years
Age maximum:
66 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Serum 25-hydroxyvitamin D Concentrations (25OHD)
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Intervention(s)
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Dietary Supplement: Vitamin D3
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Primary Outcome(s)
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Serum 25-hydroxyvitamin D (25(OH)D) concentrations
[Time Frame: Change from baseline in serum 25(OH)D concentration at 3 and 6 months]
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Secondary Outcome(s)
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Serum calcium concentration
[Time Frame: Change from baseline in serum calcium concentration at 3 and 6 months]
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Serum parathyroid hormone (PTH) concentration
[Time Frame: Change from baseline in serum PTH concentration at 3 and 6 months]
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Secondary ID(s)
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Helsinki U
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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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