NCT02349282

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

December 22, 2014

Last Update Submit

January 8, 2016

Conditions

Deficiency, Vitamin DElderly, Frail

Keywords

muscle strengthphysical performancevitamin D3CholecalciferolCalcifediol

Outcome Measures

Primary Outcomes (1)

  • Change in muscle strength, knee extension strength (measured by Biodex System)

    measured by Biodex System

    baseline, week 12, end of study (after 24 weeks supplementation)

Secondary Outcomes (15)

  • Change in knee flexion strength (measured by Biodex System)

    baseline, week 12, end of study (after 24 weeks supplementation)

  • Change in handgrip strength

    baseline, week 12, end of study (after 24 weeks supplementation)

  • Change in SPPB

    baseline, week 12, end of study (after 24 weeks supplementation)

  • Change in Timed Up and Go test

    baseline, week 12, end of study (after 24 weeks supplementation)

  • Change in Postural Body Sway

    baseline, week 12, end of study (after 24 weeks supplementation)

  • +10 more secondary outcomes

Study Arms (3)

Calcifediol 10 ug/day

EXPERIMENTAL

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

Dietary Supplement: Calcifediol 10ug/day

Vitamin D3 20 ug/day

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3 20ug/day

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Calcifediol 10ug/dayDIETARY_SUPPLEMENT
Also known as: Hy.D
Calcifediol 10 ug/day
Vitamin D3 20ug/dayDIETARY_SUPPLEMENT
Also known as: Cholecalciferol
Vitamin D3 20 ug/day
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6703HD, Netherlands

Location

Related Publications (2)

  • Hangelbroek RWJ, Vaes AMM, Boekschoten MV, Verdijk LB, Hooiveld GJEJ, van Loon LJC, de Groot LCPGM, Kersten S. No effect of 25-hydroxyvitamin D supplementation on the skeletal muscle transcriptome in vitamin D deficient frail older adults. BMC Geriatr. 2019 May 28;19(1):151. doi: 10.1186/s12877-019-1156-5.

    PMID: 31138136DERIVED

  • Vaes AMM, Tieland M, Toussaint N, Nilwik R, Verdijk LB, van Loon LJC, de Groot LCPGM. Cholecalciferol or 25-Hydroxycholecalciferol Supplementation Does Not Affect Muscle Strength and Physical Performance in Prefrail and Frail Older Adults. J Nutr. 2018 May 1;148(5):712-720. doi: 10.1093/jn/nxy024.

    PMID: 30053278DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CalcifediolCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HydroxycholecalciferolsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

January 28, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

NL(1)