RecruitingPhase 3ACTRN12607000321448

Vitamin D and Cognition Trial

A randomised, placebo controlled trial of Vitamin D in older adults with mild cognitive impairment and low vitamin D concentration to prevent cognitive decline and delay progression of cognitive decline.


Sponsor

Professor Nicola Lautenschlager

Enrollment

110 participants

Start Date

Jun 25, 2007

Study Type

Interventional

Conditions

Summary

The primary aim of this 18-month randomised, double-blind, placebo-controlled clinical trial is to establish whether vitamin D supplementation can delay progression of cognitive decline amongst older adults with Mild Cognitive Impairment (MCI) who have low vitamin D concentrations (between 12.5 and 50 nmol/L). The main hypothesis of this study is that older adults with MCI randomised to a 18-month treatment with vitamin D will experience significantly less cognitive decline (as measured with the CAMCOG) at the end of the 18-months follow-up than subjects with MCI randomised to placebo. Secondary outcomes of interest for this study include quality of life, gait, balance and muscle strength.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking vitamin D supplements for 18 months can slow down memory and thinking problems in older adults who have mild cognitive impairment (MCI) and low vitamin D levels. MCI is when a person notices some memory or thinking changes, but they are still able to carry out daily activities. Low vitamin D levels are common in older adults and have been linked to brain health. This trial aims to find out if correcting low vitamin D can protect the brain from getting worse. Researchers will also look at quality of life, walking, balance, and muscle strength. You may be eligible if: - You are over 65 years of age - You have been diagnosed with mild cognitive impairment (MCI) - Your vitamin D blood level is between 12.5 and 50 nmol/L (low range) You may NOT be eligible if: - You have been diagnosed with dementia - You have osteoporosis that requires treatment - You have no family member or friend who can provide information about you - You have had a stroke, heart attack, or fall in the last 3 months - You have had a fall with a fracture after the age of 65 - You have kidney or bladder stones - You have current severe depression or a history of schizophrenia - You have a significant hearing or vision problem that would interfere with tests Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

18-month trial of 1000 IU Vitamin D daily by oral tablet.

18-month trial of 1000 IU Vitamin D daily by oral tablet.


Locations(1)

Australia

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ACTRN12607000321448