Status:
COMPLETED
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
Lead Sponsor:
DSM Nutritional Products, Inc.
Conditions:
Pre-frail Elderly
Frail Elderly
Eligibility:
All Genders
65+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in physically frail eld...
Eligibility Criteria
Inclusion
- 25(OH)D levels between 25 - 50 nmol/L;
- 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
- Medical Illness: malabsorption syndrome: known intestinal malabsorption, celiac diseases, inflammatory bowel disease; diseases that may enhance serum calcium concentration: sarcoidosis, lymphoma, kidney stone in the last 10 years, primary hyperparathyroidism; abnormal indices of calcium metabolism, uncontrolled hypocalcaemia; diagnosed renal insufficiency, diagnosed cancer, diagnosed liver failure.
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01868945
Start Date
April 1 2013
End Date
June 1 2014
Last Update
March 27 2015
Active Locations (1)
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1
Wageningen University
Wageningen, Wageningen, Netherlands, 6700