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The Effect of Cholecalciferol in Pre-frail Elderly

NCT04847947 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-01-26

No results posted yet for this study

Summary

Vitamin D plays important role in musculoskeletal health and has been known to influence immune system. Inflammaging is one of risk factors that may contribute to development of frailty in elderly.

The purpose of this study is to determine the effects of cholecalciferol in pre-frail elderly receiving calcium supplementation on handgrip strength, gait speed, vitamin D receptor, IGF-1 and IL-6. Fall incidence and improvement of frailty status will also be assessed.

Conditions

  • Pre-frail Elderly

Interventions

DRUG

Cholecalciferol

Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks

DRUG

Placebo

Oral capsule Placebo containing white rice flour in the same identical looking with active drug once daily and Calcium Lactate 500 mg once daily for 12 weeks

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Noto Dwimartutie, MD, SpPD-KGer · Division of Geriatric, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia, Cipto Mangunkusumo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847947 on ClinicalTrials.gov