Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
Recruitment status was: Active, not recruiting
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452243
|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|