Effect of Vitamin D on Body Composition and Functionality of Older Adults

NCT07275177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-12-10

No results posted yet for this study

Summary

Older adults with obesity often experience a gradual loss of muscle mass and muscle strength, a condition sometimes described as sarcopenic obesity. This combination increases the risk of falls, disability, functional decline, and metabolic complications. Low levels of vitamin D are common in older adults and may contribute to reduced muscle function and poorer physical performance.

This study is designed to evaluate whether taking 10,000 International Units (IU) per day of vitamin D3 for 12 weeks can improve muscle strength and muscle mass in older adults with obesity living in southern Mexico. The study will also examine whether vitamin D3 supplementation influences body composition, physical performance, and serum levels of 25-hydroxyvitamin D.

Participants will complete assessments at the beginning and at the end of the 12-week period. These assessments include measurements of muscle strength, skeletal muscle mass, body fat percentage, and indicators of physical performance such as the Short Physical Performance Battery (SPPB). Additional measures of body composition and anthropometry, such as body mass index, waist circumference, and related indices, will also be recorded. Blood samples will be analyzed to determine vitamin D status.

All participants will receive daily oral vitamin D3 (cholecalciferol) throughout the 12-week intervention. The goal of the study is to understand whether improving vitamin D status can have a positive effect on muscle health and physical function in older adults with obesity.

The results from this research may help guide future strategies to prevent or reduce functional decline related to low muscle mass in older adults with obesity, particularly in rural regions of Mexico where vitamin D deficiency is common.

Conditions

  • Obesity (Disorder)
  • Obesity
  • Sarcopenia
  • Sarcopenia in Elderly
  • Sarcopenic Obesity
  • Vitamin D Deficiency
  • Vitamin D 25-Hydroxylase Deficiency
  • Muscle Strengh
  • Muscle Mass
  • Aging
  • Older Adults (65 Years and Older)
  • Functional Decline
  • Age-Related Loss of Skeletal Muscle Mass
  • Muscle Weakness

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Participants receive oral vitamin D3 (cholecalciferol) at a dose of 10,000 IU per day for 12 weeks, in addition to their usual medical care. All participants undergo baseline and post-intervention assessments of muscle strength, muscle mass, functional performance, body composition, dietary intake, and serum 25(OH)D levels.

DIETARY_SUPPLEMENT

Vitamin D placebo

Daily oral placebo capsules for 12 weeks. Placebo capsules match the vitamin D capsules in size, shape, and appearance but contain inactive ingredients only

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER
  • Universidad Autónoma Benito Juárez de Oaxaca

    lead OTHER

Principal Investigators

  • Carlos Valencia Santiago, Doctor · Universidad Autónoma Benito Juárez de Oaxaca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2024-11-09
Completion
2024-11-09

Countries

  • Mexico

Study Locations

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Entities

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 NCT07275177 on ClinicalTrials.gov