Frail Elderly, Pre-frail Elderly
Conditions
Keywords
Vitamin D3, Calcifediol 25, Frail, Dose-response
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 elderly people after 24 weeks of daily supplementation with different doses of Hy.D Calcifediol 25 SD/S compared to vitamin D3.
Interventions
DIETARY_SUPPLEMENT5 µg/day Hy.D Calcifediol
5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
DIETARY_SUPPLEMENT10 µg/day Hy.D Calcifediol
10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
DIETARY_SUPPLEMENT15 µg/day Hy.D Calcifediol
15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
DIETARY_SUPPLEMENT20 µg/day vitamin D3
20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks
Sponsors
DSM Nutritional Products, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks | 24 weeks after initial compound intake | Outcome measurement: Mean serum 25(OH)D levels after 24 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline | Baseline (day 0) | Outcome measurement: Mean serum 25(OH)D levels at baseline before supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 4 weeks | 4 weeks after initial compound intake | Outcome measurement: Mean serum 25(OH)D levels after 4 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 8 weeks | 8 weeks after initial compound intake | Outcome measurement: Mean serum 25(OH)D levels after 8 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 12 weeks | 12 weeks after initial compound intake | Outcome measurement: Mean serum 25(OH)D levels after 12 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 16 weeks | 16 weeks after initial compound intake | Outcome measurement: Mean serum 25(OH)D levels after 16 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
| Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 20 weeks | 20 weeks after initial compound intake | Outcome measurement: Mean serum 25(OH)D levels after 20 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive: 25(OH)D3 serum steady state reached? | 0, 4, 8, 12, 16, 20, 24 weeks after study start | Assessment if 25(OH)D3 serum levels will reach a steady state after 24 weeks supplementation of 3 doses of Hy.D and 1 dose of vitamin D3 |
Countries
Netherlands
Outcome results
None listed