Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
The first objective is to determine the efficacy of calcium and vitamin D supplementation at doses of 1200 mg and 800 IU, respectively, to reduce the incidence of falls and fractures in non-institutionalized elderly people.
The second objective is to measure and compare treatment groups (calcium and vitamin D vs placebo) as regards muscle strength and musculoskeletal function, bone mineral density, calcidiol level and treatment safety.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)|
- Incidence of spontaneous falls. [ Time Frame: 24 months. ] [ Designated as safety issue: No ]The primary variable will be the incidence of spontaneous falls according to the FICSIT (Frailty and Injury: Cooperative Study of Intervention Techniques) definition: "Unintentionally coming to rest on the ground, floor, or other lower level. Coming to rest against furniture or a wall was not counted as a fall".
- Consequence of falls. [ Time Frame: 24 months. ] [ Designated as safety issue: No ]Bone fractures at any location, need for healthcare, need for hospitalization, bed-ridden.
- Change in calcidiol [25(OH)D3] plasma levels [ Time Frame: 18 months. ] [ Designated as safety issue: No ]Determined by RIA (Vitamin D deficiency is defined as a calcidiol plasma level lower than 10ng/ml).
- Change in bone mass (bone density or mineral content). [ Time Frame: 24 months. ] [ Designated as safety issue: No ]By densitometry (risk of fracture). Osteoporosis will be diagnosed based on a densitometry T-score of less than 2.5 in the vertebral column, according to WHO criteria.
- Change in muscle strength in the dominant hand. [ Time Frame: 24 months ] [ Designated as safety issue: No ]Determined by dyanometry (with a mean of 3 attempts to obtain a muscle strength measurement).
- Changes in musculoskeletal function. [ Time Frame: 24 months ] [ Designated as safety issue: No ]By the timed up and go test (the elderly person gets up from a chair with arms, walks three meters, turns round, walks back and sits down again). Taking more than 20 seconds indicates a high risk for falls.
- Serious adverse events or any other adverse event. [ Time Frame: 24 months. ] [ Designated as safety issue: Yes ]An adverse event is considered as any untoward medical occurrence in any patient included in the study which does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Experimental: Calcium and vitamin D
The pharmacological intervention will be the daily administration of chewable tablets containing vitamin D and calcium.
Drug: Vitamin D and calcium suplementation
The pharmacological intervention will be the daily administration of chewable tablets containing 800 IU of vitamin D and 1200 mg of calcium. They will be administered over 2 years during the months of November to April in order to avoid the influence of sunlight.
There are many studies that associate vitamin D serum levels in older persons with muscle strength, physical performance and risk of fractures and falls. However, current evidence is insufficient to make a general recommendation for administrating calcium and vitamin D to older persons. The objective of this study is to determine the effectiveness of calcium and vitamin D supplementation in improving musculoskeletal function and decreasing the number of falls in person aged over 65 years.
Phase III, randomized, double blind, placebo-controlled trial to evaluate the efficacy of already marketed drugs in a new indication. It will be performed at Primary Care doctor visits at several Healthcare Centers in different Spanish Health Areas. A total of 704 non-institutionalized subjects aged 65 years or older will be studied (sample size calculated for a statistical power of 80%, alpha error 0.05, annual incidence of falls 30% and expected reduction of 30% to 20% and expected loss to follow up of 20%). The test drug containing 800 IU of vitamin D and 1000 mg of calcium will be administered daily. The control group will receive a placebo. The subjects will be followed up over two years. The primary variable will be the incidence of spontaneous falls. The secondary variables will include: consequences of the falls (fractures, need for hospitalization), change in calcidiol plasma levels and other analytical determinations (transaminases, PTH, calcium/phosphorous, albumin, creatinine, etc.), change in bone mass by densitometry, change in muscle strength in the dominant hand and change in musculoskeletal strength, risk factors for falls, treatment compliance, adverse effects and socio-demographic data.
|Research Unit. Primary Care Head Office of Albacete|
|Albacete, Spain, 02001|
|Principal Investigator:||Jesús López-Torres, Hidalgo||Research Unit. Primary Care Head Office of Albacete|
|Study Chair:||Ignacio Párraga Martínez, Dr.||Research Unit. Primary Care Head Office of Albacete|
|Study Chair:||Beatriz Navarro Bravo, Dr.||Research Unit. Primary Care Head Office of Albacete|
|Study Chair:||Fernando Andrés Pretel, Dr.||Research Unit. Primary Care Head Office of Albacete|