D-DOSE: 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

Sponsor

DSM Nutritional Products, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01868945

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pre-frail Elderly Frail Elderly	Dietary Supplement: 5 µg/day Hy.D Calcifediol Dietary Supplement: 10 µg/day Hy.D Calcifediol Dietary Supplement: 15 µg/day Hy.D Calcifediol Dietary Supplement: 20 µg/day vitamin D3	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5 µg/day Hy.D Calcifediol	Dietary Supplement: 5 µg/day Hy.D Calcifediol 5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
Experimental: 10 µg/day Hy.D Calcifediol	Dietary Supplement: 10 µg/day Hy.D Calcifediol 10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
Experimental: 15 µg/day Hy.D Calcifediol	Dietary Supplement: 15 µg/day Hy.D Calcifediol 15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
Active Comparator: 20 µg/day vitamin D3	Dietary Supplement: 20 µg/day vitamin D3 20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.