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

Frail Elderly Clinical Trial

— D-DOSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868945
• Other study ID #: 2012-10-24-HyD
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2013
• Last updated: March 26, 2015
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Frail Elderly
• Pre-frail Elderly

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen

Sponsors (1)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline	Outcome measurement: Mean serum 25(OH)D levels at baseline before supplementation of three doses of Hy.D and 1 dose of vitamin D3.	Baseline (day 0)	No
Primary	Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 4 weeks	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.	4 weeks after initial compound intake	No
Primary	Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 8 weeks	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.	8 weeks after initial compound intake	No
Primary	Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 12 weeks	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.	12 weeks after initial compound intake	No
Primary	Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 16 weeks	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.	16 weeks after initial compound intake	No
Primary	Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 20 weeks	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.	20 weeks after initial compound intake	No
Primary	Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks	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.	24 weeks after initial compound intake	No
Secondary	Descriptive: 25(OH)D3 serum steady state reached?	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	0, 4, 8, 12, 16, 20, 24 weeks after study start	No