Obesity (Disorder)NCT07275177
Effect of Vitamin D on Body Composition and Functionality of Older Adults
A study testing Vitamin D in people with Obesity (Disorder) and Obesity, run by Universidad Autónoma Benito Juárez de Oaxaca at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Obesity (Disorder), Obesity, Sarcopenia
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteMexico
- Study dates
- 9 Jan 2024to 9 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano del Seguro Social - Unidad de Medicina Familiar 24, Miahuatlán de Porfirio Díaz, Oaxaca, México
Miahuatlán de Porfirio Díaz, Oaxaca, 70805
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Obesity (Disorder), Obesity, Sarcopenia, Sarcopenia in Elderly, Sarcopenic Obesity, Vitamin D Deficiency
- Being tested
- Vitamin D, Vitamin D placebo
- Keywords
- Sarcopenic Obesity, Obesity, Sarcopenia, Vitamin D deficiency, Muscle Weakness, Functional Decline, Aging, Older Adults
- Medical subject headings
- Obesity, Sarcopenia, Vitamin D Deficiency, Vitamin D Hydroxylation-Deficient Rickets, Type 1B, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary 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 placeboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Vitamin D placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Skeletal muscle mass
Skeletal Muscle mass assessed by Bioelectrical Impedance Analysis (BIA). Results reported in kilograms (kg)
Measured: Baseline and 12 weeks
Secondary outcomes (10)
Body Fat percentage
Total body fat percentage measured using bioelectrical impedance analysis (BIA). The results will be expressed as a percentage (%)
Measured: Baseline and 12 weeks
Visceral Fat Index
Visceral fat index obtained through Bioelectrical Impedance Analysis (BIA). The results will be expressed in index units
Measured: Baseline and 12 weeks
Body Adiposity Index (BAI)
Body Adiposity Index calculated from hip circumference and height. The results will be expressed in index units
Measured: Baseline and 12 weeks
Short physical Performance Battery (SPPB) Score
Functional performance assessed using the SPPB, wich includes balance tests, gait speed, and chair stands.
Measured: Baseline and 12 weeks
Serum 25-Hydroxyvitamin D Levels
Serum levels of 25-hydroxyvitamin D [25(OH)D], measured in nanograms per mililiter (ng/mL)
Measured: Baseline and 12 weeks
SPPB Score
Short Physical Performance Battery (SPPB) score, ranging from 0 (worst performance) to 12 (best performance). Higher scores indicate better physical function.
Measured: Baseline and 12 weeks
Weight
Body weight measured in kilograms (kg)
Measured: baseline and 12 weeks
Body Mass Index (BMI)
Body Mass Index (BMI) calculated as weight (kg) divided by height squared (m2). The results will be expressed in kg/m2
Measured: Baseline and 12 weeks
Waist circumference
Waist circumference measured in centimeters (cm)
Measured: Baseline and 12 weeks
Metabolic Age
Metabolic Age estimated by BIA based on body composition paremeters. The results will be expressed in years
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start9 Jan 2024
- Primary completion9 Nov 2024
- Study completion9 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma Benito Juárez de Oaxaca
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Carlos Valencia Santiago, Universidad Autónoma Benito Juárez de Oaxaca
- Investigators
- Carlos Valencia Santiago, Doctor, Principal investigator, Universidad Autónoma Benito Juárez de Oaxaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275177
- Sponsor's protocol ID
- ESV/CIUU/290923
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study was conducted within a clinical care setting of IMSS and contains protected health information. Data are restricted by institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07275177
- Acronym / sponsor ID
- ESV/CIUU/290923
- Conditions
- Obesity (Disorder), Obesity, Sarcopenia, Sarcopenia in Elderly, Sarcopenic Obesity, Vitamin D Deficiency
- Keywords
- Sarcopenic Obesity, Obesity, Sarcopenia, Vitamin D deficiency, Muscle Weakness, Functional Decline, Aging, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidad Autónoma Benito Juárez de OaxacaUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation (Cholecalciferol) | Experimental | Dietary Supplement: Vitamin DParticipants 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. |
| Placebo capsule | Placebo comparator | Dietary Supplement: Vitamin D placeboDaily oral placebo capsules for 12 weeks. Placebo capsules match the vitamin D capsules in size, shape, and appearance but contain inactive ingredients only. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DParticipants 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 supplementation (Cholecalciferol) |
| Vitamin D placeboDaily 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 | Placebo capsule |
Primary outcome
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.
Skeletal muscle mass
Time frame: Baseline and 12 weeks
Skeletal Muscle mass assessed by Bioelectrical Impedance Analysis (BIA). Results reported in kilograms (kg)
10 secondary outcomes
Body Fat percentage
Time frame: Baseline and 12 weeks
Visceral Fat Index
Time frame: Baseline and 12 weeks
Body Adiposity Index (BAI)
Time frame: Baseline and 12 weeks
Short physical Performance Battery (SPPB) Score
Time frame: Baseline and 12 weeks
Serum 25-Hydroxyvitamin D Levels
Time frame: Baseline and 12 weeks
SPPB Score
Time frame: Baseline and 12 weeks
Weight
Time frame: baseline and 12 weeks
Body Mass Index (BMI)
Time frame: Baseline and 12 weeks
Waist circumference
Time frame: Baseline and 12 weeks
Metabolic Age
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study was conducted within a clinical care setting of IMSS and contains protected health information. Data are restricted by institutional and ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Valencia Santiago, Doctor principal investigator
Universidad Autónoma Benito Juárez de Oaxaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Obesity (Disorder) and Obesity, run by Universidad Autónoma Benito Juárez de Oaxaca at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip strehgth (kg) (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.