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

NCT07275177 | Completed DMC

• 1 other identifier: ESV/CIUU/290923
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

Sarcopenic Obesity; Obesity; Sarcopenia; Vitamin D deficiency; Muscle Weakness; Functional Decline; Aging; Older Adults

Outcome Measures

Primary Outcomes (2)

• Handgrip strehgth (kg)

  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.

  Baseline and 12 weeks

• Skeletal muscle mass

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

  Baseline and 12 weeks

Secondary Outcomes (10)

• Body Fat percentage

  Baseline and 12 weeks

• Visceral Fat Index

  Baseline and 12 weeks

• Body Adiposity Index (BAI)

  Baseline and 12 weeks

• Short physical Performance Battery (SPPB) Score

  Baseline and 12 weeks

• Serum 25-Hydroxyvitamin D Levels

  Baseline and 12 weeks

Study Arms (2)

Vitamin D supplementation (Cholecalciferol)

EXPERIMENTAL

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 capsule

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin D placebo

Interventions

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 supplementation (Cholecalciferol)

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

Placebo capsule

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Council of Science and Technology, Mexico: collaborator
• Universidad Autónoma Benito Juárez de Oaxaca: lead

Study Sites (1)

Instituto Mexicano del Seguro Social - Unidad de Medicina Familiar 24, Miahuatlán de Porfirio Díaz, Oaxaca, México

Miahuatlán de Porfirio Díaz, Oaxaca, 70805, Mexico

Location

MeSH Terms

Conditions

Obesity; Sarcopenia; Vitamin D Deficiency; Vitamin D Hydroxylation-Deficient Rickets, Type 1B; Muscle Weakness

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Avitaminosis; Deficiency Diseases; Malnutrition; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Carlos Valencia Santiago, Doctor

  Universidad Autónoma Benito Juárez de Oaxaca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to group assignment. Vitamin D3 capsules and placebo capsules were identical in size, color, and appearance. Investigators administering the supplementation and collecting outcomes were aware of allocation, but participants did not know whether they were receiving vitamin D or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned to one of two parallel groups. The intervention group received daily oral vitamin D3 (10,000 IU/day) for 12 weeks. The placebo group received a daily oral placebo capsule identical in appearance. All participants completed identical baseline and post-intervention assessments, including anthropometry, body composition, muscle strength, physical performance (SPPB), dietary intake, and serum 25(OH)D levels.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start: January 9, 2024
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)