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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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14 September 2015 |
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Main ID: |
NCT02543671 |
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Date of registration:
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03/09/2015 |
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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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Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency
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Scientific title:
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Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02543671 |
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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, Masking: Single Blind (Subject), 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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Greece
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Contacts
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Name:
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Yannis Manios, Associate 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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Harokopio University, Athens |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- subjects are eligible if they are 55-75 years of age
- being at menopause for more than 5 years
- they used to consume cheese daily
- those with a Body Mass Index (BMI) range 20-33kg/m2
Exclusion Criteria:
- having any disease/ pathology that interacts with vitamin D metabolism
- taking medications that interact with vitamin D metabolism or vitamin D supplements
for medical reasons (e.g. osteoporosis)
- planned vacation to a sunny holiday destination during the intervention period
- having a cow's milk allergy
- having a drugs and/or alcohol abuse
Age minimum:
55 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hypovitaminosis D
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Deficiency of Micronutrients
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Intervention(s)
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Other: plain (non-fortified) reduced-fat yellow cheese
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Other: vitamin D3 enriched, reduced-fat yellow cheese
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Primary Outcome(s)
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serum 25-hydroxyvitamin D concentration
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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role limitations due to physical health scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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vitality scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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emotional well-being scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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physical functioning scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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bodily pain scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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role limitations due to emotional problems scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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social functioning scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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general health scale, Short Form 36 health survey questionnaire (SF-36)
[Time Frame: 8 weeks]
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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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