Dose Finding Study in Physically Frail Elderly to Measure 25(OH) Vitamin D Levels After Supplementation With Hy.D Calcifediol 25 SD/S and Vitamin D3
NCT ID: NCT01868945
Last Updated: 2015-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2013-04-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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5 µg/day Hy.D Calcifediol
5 µg/day Hy.D Calcifediol
5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
10 µg/day Hy.D Calcifediol
10 µg/day Hy.D Calcifediol
10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
15 µg/day Hy.D Calcifediol
15 µg/day Hy.D Calcifediol
15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
20 µg/day vitamin D3
20 µg/day vitamin D3
20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks
Interventions
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5 µg/day Hy.D Calcifediol
5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
10 µg/day Hy.D Calcifediol
10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
15 µg/day Hy.D Calcifediol
15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
20 µg/day vitamin D3
20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Age 65 and older;
* Physically frail, based on the criteria designed by Fried et al. \[1\]. Frailty will be defined as a clinical syndrome in which one or more of the following criteria are present: unintentional weight loss (4.5 kg in past year), selfreported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). These criteria are easily assessable and have been commonly used to determine frailty;
* Men and women;
* Body mass index between 20 and 35 kg/m2 (used for stratification);
* Willingness and ability to comply with the protocol.
Exclusion Criteria
* Hypercalcemia : serum calcium adjusted for albumin of \> 2.6 nmol/L.
* Medication: bisphosphonate or Parathyroid hormone (PTH) treatment, tuberculostatics, epilepsy medication, interfering with vitamin D metabolism and vitamin D supplementation.
* Use of vitamin D supplementation in the last three months (excluding multivitamin supplementation).
* Not willing to stop the use of multivitamin supplementation during the study.
* (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort).
* Patient heavily consumes alcohol containing products defined as greater than (\>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
* Donating blood in the period of 2 months before, until 1 month after the end of the study.
* Planned surgery.
* Participation in another clinical trial.
65 Years
ALL
Yes
Sponsors
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DSM Nutritional Products, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lisette De Groot, Prof
Role: PRINCIPAL_INVESTIGATOR
Wageningen University
Michael Tieland, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen University
Luc van Loon, Prof
Role: PRINCIPAL_INVESTIGATOR
Maastricht University
Locations
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Wageningen University
Wageningen, Wageningen, Netherlands
Countries
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References
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Vaes AMM, Tieland M, de Regt MF, Wittwer J, van Loon LJC, de Groot LCPGM. Dose-response effects of supplementation with calcifediol on serum 25-hydroxyvitamin D status and its metabolites: A randomized controlled trial in older adults. Clin Nutr. 2018 Jun;37(3):808-814. doi: 10.1016/j.clnu.2017.03.029. Epub 2017 Mar 31.
Other Identifiers
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2012-10-24-HyD
Identifier Type: -
Identifier Source: org_study_id
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