The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population (D-Fit)

Wageningen University

Status: Completed

Conditions: Deficiency, Vitamin D; Elderly, Frail

Treatments: Dietary Supplement: Vitamin D3 20ug/day; Dietary Supplement: Placebo; Dietary Supplement: Calcifediol 10ug/day

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02349282

NL48127.081.148

Details and patient eligibility

About

In an ageing population, the need for interventions to help older people remain healthy, active and independent for as long as possible, increases. Although several studies suggest a beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical functioning, particularly in vulnerable populations, results are contradicting. Randomized, placebo-controlled trials are needed to further establish the effect of vitamin D on muscle strength in the frail elderly population.The primary aim of this study is to determine the effect of daily supplementation with two different forms of vitamin D on muscle strength in frail elderly people over a period of 24 weeks.

Enrollment: 78 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 25(OH)D levels 20-50 nmol/L.
• age 65 or older.
• physically frail (pre-frail or frail, based on the criteria designed by Fried et al.) (30). 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), self-reported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). More details on these criteria are described in chapter 6.3.2.
• body mass index between 18.5 and 35 kg/m2.
• willingness and ability to comply with the protocol, including performance of the knee extension strength test.

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; currently diagnosed or undergoing treatment.

• Hypercalcemia: serum calcium adjusted for albumin of > 2.6 nmol/L.

• Medication: interfering with vitamin D metabolism and vitamin D supplementation (bisphosphonate, PTH treatment, tuberculostatica, anti-epileptica).

• Subject not able (when medically necessary/ advised) or not willing to stop the use of vitamin D containing supplements during the study.

• (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort) during intervention period.

• Patient heavily consumes alcohol containing products defined as greater than > 21 drinks of alcoholic beverages per week.

• Planned surgery which can affect study measures (taking into account duration of hospitalisation and recovery).

• Participation in another clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 3 patient groups, including a placebo group

Calcifediol 10 ug/day

Experimental group

Description:

Capsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.

Treatment:

Dietary Supplement: Calcifediol 10ug/day

Vitamin D3 20 ug/day

Experimental group

Description:

Capsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.

Treatment:

Dietary Supplement: Vitamin D3 20ug/day

Placebo

Placebo Comparator group

Description:

Capsule without active ingredients, taken together with breakfast for a total period of 24 weeks.

Treatment:

Dietary Supplement: Placebo