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Completed

NCT Number: NCT07275177

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

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.

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Key information

About this study

This randomized controlled study investigated the effects of vitamin D3 supplementation on muscle strength, body composition, and functional performance in older adults with obesity. Vitamin D deficiency is highly prevalent in this population and has been associated with reduced skeletal muscle mass, decreased physical performance, increased fat accumulation, and progression toward frailty. Improving vitamin D status may contribute to better musculoskeletal health and improved physical function.

Participants received 10,000 International Units (IU) per day of vitamin D3 for a total period of 12 weeks. All assessments were conducted at baseline and at week 12. Handgrip strength was measured using a Jamar hand dynamometer as an indicator of muscle strength. Skeletal muscle mass, body fat percentage, visceral fat index, metabolic age, and related measures were obtained via Bioelectrical Impedance Analysis (BIA). Anthropometric variables including weight, body mass index (BMI), waist circumference, abdominal volume index (AVI), and body adiposity index (BAI) were also recorded.

Functional status was assessed using the Short Physical Performance Battery (SPPB), a validated tool consisting of balance, gait speed, and chair stand tests. The SPPB ranges from 0 to 12 points, with higher scores indicating better physical performance.

Serum concentrations of 25-hydroxyvitamin D [25(OH)D] were evaluated using standardized laboratory techniques to determine changes in vitamin D status associated with supplementation.

This study seeks to clarify whether vitamin D3 supplementation can improve muscle strength, muscle mass, functional performance, and body composition among older adults with obesity, and to better understand the role of vitamin D in age-related musculoskeletal decline.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 60 years or older.
  • Diagnosis of obesity (BMI ≥ 30 kg/m²).
  • Patients attending the outpatient clinic of IMSS No. 24 in Miahuatlán de Porfirio Díaz, Oaxaca.
  • Able to perform physical and functional tests (handgrip, SPPB).
  • Capable of providing informed consent.
  • Willing to comply with the intervention and attend baseline and 12-week evaluations.

Exclusion criteria

  • Known diagnosis of hypercalcemia or disorders of calcium metabolism.
  • Current use of high-dose vitamin D supplementation or medications affecting vitamin D metabolism.
  • Severe renal or hepatic disease.
  • Active cancer treatment.
  • Neurological or musculoskeletal conditions that impair mobility or functional testing (e.g., recent fractures, severe osteoarthritis, stroke with major disability).
  • Cognitive impairment preventing the understanding of instructions or informed consent.
  • Any medical condition that, in the judgment of investigators, would interfere with participation or pose additional risk.
  • Participation in another clinical trial during the study period.

Treatment and study plan

Vitamin D

Dietary Supplement

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.

Vitamin D placebo

Dietary Supplement

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

Primary outcomes

  1. Handgrip strehgth (kg)

    Time frame: Baseline and 12 weeks

    Muscle strength will be measured using a handheld dynamometer following standardized procedures. The highest value from two attempts per hand will be used. Results reported in kilograms (kg). Higher values indicate greater muscle strength.

  2. Skeletal muscle mass

    Time frame: Baseline and 12 weeks

    Skeletal Muscle mass assessed by Bioelectrical Impedance Analysis (BIA). Results reported in kilograms (kg)

Secondary outcomes

  1. Body Fat percentage

    Time frame: Baseline and 12 weeks

    Total body fat percentage measured using bioelectrical impedance analysis (BIA). The results will be expressed as a percentage (%)

  2. Visceral Fat Index

    Time frame: Baseline and 12 weeks

    Visceral fat index obtained through Bioelectrical Impedance Analysis (BIA). The results will be expressed in index units

  3. Body Adiposity Index (BAI)

    Time frame: Baseline and 12 weeks

    Body Adiposity Index calculated from hip circumference and height. The results will be expressed in index units

  4. Short physical Performance Battery (SPPB) Score

    Time frame: Baseline and 12 weeks

    Functional performance assessed using the SPPB, wich includes balance tests, gait speed, and chair stands.

  5. Serum 25-Hydroxyvitamin D Levels

    Time frame: Baseline and 12 weeks

    Serum levels of 25-hydroxyvitamin D [25(OH)D], measured in nanograms per mililiter (ng/mL)

  6. SPPB Score

    Time frame: Baseline and 12 weeks

    Short Physical Performance Battery (SPPB) score, ranging from 0 (worst performance) to 12 (best performance). Higher scores indicate better physical function.

  7. Weight

    Time frame: baseline and 12 weeks

    Body weight measured in kilograms (kg)

  8. Body Mass Index (BMI)

    Time frame: Baseline and 12 weeks

    Body Mass Index (BMI) calculated as weight (kg) divided by height squared (m2). The results will be expressed in kg/m2

  9. Waist circumference

    Time frame: Baseline and 12 weeks

    Waist circumference measured in centimeters (cm)

  10. Metabolic Age

    Time frame: Baseline and 12 weeks

    Metabolic Age estimated by BIA based on body composition paremeters. The results will be expressed in years

Sponsors and collaborators

Lead sponsor

Universidad Autónoma Benito Juárez de Oaxaca

Other

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

Effect of Vitamin D Supplementation on Strength and Muscle Gain in Older Adults With Obesity in Miahuatlán de Porfirio Díaz, in Period 2023-2024

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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