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

Phase 1

Completed

• Conditions: Pre-frail Elderly; Frail Elderly
• Interventions: 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

• Registration Number: NCT01868945
• Lead Sponsor: DSM Nutritional Products, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 µg/day Hy.D Calcifediol	5 µg/day Hy.D Calcifediol	-
10 µg/day Hy.D Calcifediol	10 µg/day Hy.D Calcifediol	-
15 µg/day Hy.D Calcifediol	15 µg/day Hy.D Calcifediol	-
20 µg/day vitamin D3	20 µg/day vitamin D3	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Netherlands