Duchenne Muscular Dystrophy (DMD)NCT06682585
Nutritional Status and Therapy in DMD Patients
A study testing Individualised dietary intervention in people with Duchenne Muscular Dystrophy (DMD), run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary The goal of this clinical trial is to evaluate the impact of a disease-specific, individualized diet on the nutritional status and functional abilities of Duchenne muscular dystrophy (DMD) patients. The study will focus on children aged 4-8 years residing in Ankara, Turkey. Read more about this study
- Who is it for?
- Ages 48 to 96 months, men only
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- Individualised dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2024to 21 Feb 2025
- 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 48 to 96 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Duchenne Muscular Dystrophy (DMD) Must be between 4 and 8 years old Able to ambulate independently Must be residing in Ankara province, Turkey Must be willing to participate and adhere to the dietary intervention, as confirmed by both the patient and their legal guardian(s) Must be currently receiving corticosteroid therapy
Who cannot join
- Inability to read and write in Turkish Wheelchair-bound or unable to ambulate independently Significant liver or kidney dysfunction Scheduled for major surgery within 6 months of study enrollment Symptoms of dysphagia and swallowing difficulties Significant respiratory distress or respiratory insufficiency requiring mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Nutritional Status of Duchenne Muscular Dystrophy Patients and Evaluation of the Effectiveness of Disease-Specific Nutrition Therapy
Brief Summary
The goal of this clinical trial is to evaluate the impact of a disease-specific, individualized diet on the nutritional status and functional abilities of Duchenne muscular dystrophy (DMD) patients. The study will focus on children aged 4-8 years residing in Ankara, Turkey.
Read more
Key questions the investigators aim to answer:
Can a tailored dietary intervention improve the nutritional status of DMD patients? Does a specialized diet positively impact the functional abilities of DMD patients, as measured by the North Star Ambulation Assessment (NSAA)? Participants will undergo a comprehensive nutritional assessment, including anthropometric measurements, and will receive individualized dietary counseling. The intervention will focus on optimizing energy, protein, calcium, and fluid intake, as well as addressing the potential side effects of corticosteroid therapy.
The primary outcome measure will be changes in nutritional status, as assessed by anthropometric measurements. Secondary outcome measures will include changes in functional abilities as measured by the NSAA and quality of life assessments.
Read the detailed description
Study Objective This study aims to investigate the efficacy of a disease-specific, individualized dietary intervention in improving the nutritional status and functional abilities of Duchenne Muscular Dystrophy (DMD) patients aged 4-8 years residing in Ankara, Turkey.
Study Design This is a prospective, interventional study. Intervention
A 12-week individualized dietary intervention will be implemented for each participant. The intervention will focus on:
- Energy Intake: Caloric needs will be calculated based on the patient's age, weight, and activity level, taking into account the potential impact of corticosteroid therapy on energy expenditure.
- Protein Intake: Protein requirements will be met through a balanced diet, aiming to optimize muscle protein synthesis.
- Calcium and Vitamin D Intake: Adequate intake of these nutrients will be emphasized to support bone health and prevent osteoporosis.
- Fluid Intake: Fluid intake will be monitored to prevent dehydration and constipation.
- Carbohydrate Intake: A low-glycemic index diet will be recommended to manage blood glucose levels and insulin resistance, especially in patients on corticosteroid therapy.
- Sodium Intake: Sodium intake will be restricted to minimize fluid retention and hypertension.
Outcome Measures Changes in anthropometric measurements (body weight, height, BMI, skinfold measurements) Changes in functional abilities as assessed by the North Star Ambulation Assessment (NSAA) Changes in functional abilities as assessed by handgrip strenght Changes in micro and micro nutrient intake as assessed by three-day food consumption record Data Collection Data will be collected through face-to-face interviews with parents or primary caregivers and patients with DMD. After the first interview, a second interview will be conducted 12 weeks after the personalized diet has been planned.
Baseline Assessment:
- Demographic information
- Medical history
- Nutritional assessment (anthropometric measurements, dietary intake assessment)
- Functional assessment (NSAA)
Follow-up Assessments:
- Anthropometric measurements
- Functional assessment (NSAA)
- Dietary intake assessment Data Analysis Statistical analysis will be performed using appropriate statistical software. Descriptive statistics will be used to summarize the baseline characteristics of the participants. Parametric or non-parametric tests will be used to compare pre- and post-intervention outcomes, as appropriate.
Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki and approved by the local ethics committee. Informed consent will be obtained from the parents or legal guardians of the participants.
By addressing the specific nutritional needs of DMD patients, this study aims to improve their overall health and quality of life.
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- Individualised dietary intervention
- Keywords
- Duchenne Muscular Dystrophy, Nutrition
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised dietary interventionOther
- Energy Intake: Caloric needs will be calculated based on the patient's age, weight, and activity level, taking into account the potential impact of corticosteroid therapy on energy expenditure.
- Protein Intake: Protein requirements will be met through a balanced diet, aiming to optimize muscle protein synthesis.
- Calcium and Vitamin D Intake: Adequate intake of these nutrients will be emphasized to support bone health and prevent osteoporosis.
- Fluid Intake: Fluid intake will be monitored to prevent dehydration and constipation.
- Carbohydrate Intake: A low-glycemic index diet will be recommended to manage blood glucose levels and insulin resistance, especially in patients on corticosteroid therapy.
- Sodium Intake: Sodium intake will be restricted to minimize fluid retention and hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | The participants of the arm will follow diet program specially prepared for them for 12 weeks. Receives: Other: Individualised dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
Changes in body weight (kg). Body weight will be measured with an electronic scale sensitive to 0.1 kilograms.
Measured: From enrollment to the end of diet at 12 weeks
Anthropometric measurements
Changes in skinfold thickness (triceps, biceps, subscapular, and suprailiac) (in millimeters) Skinfold thickness will be compared to the World Health Organization's percentile and Z score charts to determine adequacy, deficiency, or excess.
Measured: From enrollment to the end of diet at 12 weeks
Anthropometric measurements
Changes in height (cm). Height is measured with the individual standing upright and the head in the Frankfurt plane (the orbitale point and tragion point are set to be on the horizontal plane), while the vertical distance from the ground to the vertex, which is the highest point of the head, will be measured with a tape measure on a fixed plane.
Measured: From enrollment to the end of diet at 12 weeks
Anthropometric measurements
Changes in Body Mass Index (BMI)(kg/m²). BMI will be obtained by dividing the particioant's body weight in kg by the square of the height in meters.
Body mass index will be evaluated with the World Health Organization's percentile and Z score charts.
Measured: From enrollment to the end of diet at 12 weeks
Secondary outcomes (2)
Functional Ability
Changes in the North Star Ambulation Assessment (NSAA) score meausered by a specialist physiotherapist. The total score varies between 0-34. A higher score indicates better ambulation and motor function.
Measured: From enrollment to the end of diet at 12 weeks
Functional Ability
Changes in hand grip strength measured by hand dynamometry (in kilograms)
Measured: From enrollment to the end of diet at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start18 Nov 2024
- Primary completion20 Feb 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül ULU, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682585
- Sponsor's protocol ID
- 111-659-22
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Summer SS, Wong BL, Rutter MM, Horn PS, Tian C, Rybalsky I, Shellenbarger KC, Kalkwarf HJ. Age-related changes in appendicular lean mass in males with Duchenne muscular dystrophy: A retrospective review. Muscle Nerve. 2021 Feb;63(2):231-238. doi: 10.1002/mus.27107. Epub 2020 Dec 7.
PubMed 33104257Guzikowska E, Markiewicz-Loskot G, Hercog R. [Serum opsonization activity in children with recurrent respiratory tract infections]. Pediatr Pol. 1986 Dec;61(12):780-3. No abstract available. Polish.
PubMed 3601481Billich N, Evans M, Truby H, Ryan MM, Davidson ZE. The association between dietary factors and body weight and composition in boys with Duchenne muscular dystrophy. J Hum Nutr Diet. 2022 Oct;35(5):804-815. doi: 10.1111/jhn.12987. Epub 2022 Feb 1.
PubMed 34936149de Souza Costa AD, Vermeulen-Serpa KM, Batista Marinho KM, Carvalho Xavier de Medeiros CA, Antunes de Araujo A, Teixeira Dourado-Junior ME, Brandao-Neto J, Lima Maciel BL, Helena de Lima Vale S. Persistent inflammation and nutritional status in Duchenne muscular dystrophy. Clin Nutr ESPEN. 2024 Jun;61:393-398. doi: 10.1016/j.clnesp.2024.04.014. Epub 2024 Apr 20.
PubMed 38777460Chou E, Lindeback R, D'Silva AM, Sampaio H, Neville K, Farrar MA. Growth and nutrition in pediatric neuromuscular disorders. Clin Nutr. 2021 Jun;40(6):4341-4348. doi: 10.1016/j.clnu.2021.01.013. Epub 2021 Jan 22.
PubMed 33551221Davidson ZE, Ryan MM, Kornberg AJ, Sinclair K, Cairns A, Walker KZ, Truby H. Observations of body mass index in Duchenne muscular dystrophy: a longitudinal study. Eur J Clin Nutr. 2014 Aug;68(8):892-7. doi: 10.1038/ejcn.2014.93. Epub 2014 May 14.
PubMed 24824013Duan D, Goemans N, Takeda S, Mercuri E, Aartsma-Rus A. Duchenne muscular dystrophy. Nat Rev Dis Primers. 2021 Feb 18;7(1):13. doi: 10.1038/s41572-021-00248-3.
PubMed 33602943Garcia-Rodriguez R, Hiller M, Jimenez-Gracia L, van der Pal Z, Balog J, Adamzek K, Aartsma-Rus A, Spitali P. Premature termination codons in the DMD gene cause reduced local mRNA synthesis. Proc Natl Acad Sci U S A. 2020 Jul 14;117(28):16456-16464. doi: 10.1073/pnas.1910456117. Epub 2020 Jul 2.
PubMed 32616572Aartsma-Rus A, Van Deutekom JC, Fokkema IF, Van Ommen GJ, Den Dunnen JT. Entries in the Leiden Duchenne muscular dystrophy mutation database: an overview of mutation types and paradoxical cases that confirm the reading-frame rule. Muscle Nerve. 2006 Aug;34(2):135-44. doi: 10.1002/mus.20586.
PubMed 16770791Mercuri E, Bonnemann CG, Muntoni F. Muscular dystrophies. Lancet. 2019 Nov 30;394(10213):2025-2038. doi: 10.1016/S0140-6736(19)32910-1.
PubMed 31789220Davis J, Samuels E, Mullins L. Nutrition Considerations in Duchenne Muscular Dystrophy. Nutr Clin Pract. 2015 Aug;30(4):511-21. doi: 10.1177/0884533615586202. Epub 2015 May 14.
PubMed 25977513Bernabe-Garcia M, Rodriguez-Cruz M, Atilano S, Cruz-Guzman ODR, Almeida-Becerril T, Calder PC, Gonzalez J. Body composition and body mass index in Duchenne muscular dystrophy: Role of dietary intake. Muscle Nerve. 2019 Mar;59(3):295-302. doi: 10.1002/mus.26340. Epub 2018 Dec 12.
PubMed 30194761
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Nutritional Status of Duchenne Muscular Dystrophy Patients and Evaluation of the Effectiveness of Disease-Specific Nutrition Therapy
- ClinicalTrials.gov ID
- NCT06682585
- Acronym / sponsor ID
- 111-659-22
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Keywords
- Duchenne Muscular Dystrophy, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 12 Nov 2024 (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.
Brief Summary
The goal of this clinical trial is to evaluate the impact of a disease-specific, individualized diet on the nutritional status and functional abilities of Duchenne muscular dystrophy (DMD) patients. The study will focus on children aged 4-8 years residing in Ankara, Turkey.
Key questions the investigators aim to answer:
Can a tailored dietary intervention improve the nutritional status of DMD patients? Does a specialized diet positively impact the functional abilities of DMD patients, as measured by the North Star Ambulation Assessment (NSAA)? Participants will undergo a comprehensive nutritional assessment, including anthropometric measurements, and will receive individualized dietary counseling. The intervention will focus on optimizing energy, protein, calcium, and fluid intake, as well as addressing the potential side effects of corticosteroid therapy.
The primary outcome measure will be changes in nutritional status, as assessed by anthropometric measurements. Secondary outcome measures will include changes in functional abilities as measured by the NSAA and quality of life assessments.
Detailed description
Study Objective This study aims to investigate the efficacy of a disease-specific, individualized dietary intervention in improving the nutritional status and functional abilities of Duchenne Muscular Dystrophy (DMD) patients aged 4-8 years residing in Ankara, Turkey.
Study Design This is a prospective, interventional study. Intervention
A 12-week individualized dietary intervention will be implemented for each participant. The intervention will focus on:
- Energy Intake: Caloric needs will be calculated based on the patient's age, weight, and activity level, taking into account the potential impact of corticosteroid therapy on energy expenditure.
- Protein Intake: Protein requirements will be met through a balanced diet, aiming to optimize muscle protein synthesis.
- Calcium and Vitamin D Intake: Adequate intake of these nutrients will be emphasized to support bone health and prevent osteoporosis.
- Fluid Intake: Fluid intake will be monitored to prevent dehydration and constipation.
- Carbohydrate Intake: A low-glycemic index diet will be recommended to manage blood glucose levels and insulin resistance, especially in patients on corticosteroid therapy.
- Sodium Intake: Sodium intake will be restricted to minimize fluid retention and hypertension.
Outcome Measures Changes in anthropometric measurements (body weight, height, BMI, skinfold measurements) Changes in functional abilities as assessed by the North Star Ambulation Assessment (NSAA) Changes in functional abilities as assessed by handgrip strenght Changes in micro and micro nutrient intake as assessed by three-day food consumption record Data Collection Data will be collected through face-to-face interviews with parents or primary caregivers and patients with DMD. After the first interview, a second interview will be conducted 12 weeks after the personalized diet has been planned.
Baseline Assessment:
- Demographic information
- Medical history
- Nutritional assessment (anthropometric measurements, dietary intake assessment)
- Functional assessment (NSAA)
Follow-up Assessments:
- Anthropometric measurements
- Functional assessment (NSAA)
- Dietary intake assessment Data Analysis Statistical analysis will be performed using appropriate statistical software. Descriptive statistics will be used to summarize the baseline characteristics of the participants. Parametric or non-parametric tests will be used to compare pre- and post-intervention outcomes, as appropriate.
Ethical Considerations The study will be conducted in accordance with the Declaration of Helsinki and approved by the local ethics committee. Informed consent will be obtained from the parents or legal guardians of the participants.
By addressing the specific nutritional needs of DMD patients, this study aims to improve their overall health and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Other: Individualised dietary interventionThe participants of the arm will follow diet program specially prepared for them for 12 weeks. |
Who may qualify
- Ages
- 48 to 96 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of Duchenne Muscular Dystrophy (DMD) Must be between 4 and 8 years old Able to ambulate independently Must be residing in Ankara province, Turkey Must be willing to participate and adhere to the dietary intervention, as confirmed by both the patient and their legal guardian(s) Must be currently receiving corticosteroid therapy
Key exclusion criteria (1 listed)
- Inability to read and write in Turkish Wheelchair-bound or unable to ambulate independently Significant liver or kidney dysfunction Scheduled for major surgery within 6 months of study enrollment Symptoms of dysphagia and swallowing difficulties Significant respiratory distress or respiratory insufficiency requiring mechanical ventilation.
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 |
|---|---|---|
| Individualised dietary intervention* Energy Intake: Caloric needs will be calculated based on the patient's age, weight, and activity level, taking into account the potential impact of corticosteroid therapy on energy expenditure. * Protein Intake: Protein requirements will be met through a balanced diet, aiming to optimize muscle protein synthesis. * Calcium and Vitamin D Intake: Adequate intake of these nutrients will be emphasized to support bone health and prevent osteoporosis. * Fluid Intake: Fluid intake will be monitored to prevent dehydration and constipation. * Carbohydrate Intake: A low-glycemic index diet will be recommended to manage blood glucose levels and insulin resistance, especially in patients on corticosteroid therapy. * Sodium Intake: Sodium intake will be restricted to minimize fluid retention and hypertension. | Other | Dietary Intervention |
Primary outcome
Anthropometric measurements
Time frame: From enrollment to the end of diet at 12 weeks
Changes in body weight (kg). Body weight will be measured with an electronic scale sensitive to 0.1 kilograms.
Anthropometric measurements
Time frame: From enrollment to the end of diet at 12 weeks
Changes in skinfold thickness (triceps, biceps, subscapular, and suprailiac) (in millimeters) Skinfold thickness will be compared to the World Health Organization's percentile and Z score charts to determine adequacy, deficiency, or excess.
Anthropometric measurements
Time frame: From enrollment to the end of diet at 12 weeks
Changes in height (cm). Height is measured with the individual standing upright and the head in the Frankfurt plane (the orbitale point and tragion point are set to be on the horizontal plane), while the vertical distance from the ground to the vertex, which is the highest point of the head, will be measured with a tape measure on a fixed plane.
Anthropometric measurements
Time frame: From enrollment to the end of diet at 12 weeks
Changes in Body Mass Index (BMI)(kg/m²). BMI will be obtained by dividing the particioant's body weight in kg by the square of the height in meters. Body mass index will be evaluated with the World Health Organization's percentile and Z score charts.
2 secondary outcomes
Functional Ability
Time frame: From enrollment to the end of diet at 12 weeks
Functional Ability
Time frame: From enrollment to the end of diet at 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 21 Nov 2025.
- Background: PubMed 33104257Summer SS, Wong BL, Rutter MM, Horn PS, Tian C, Rybalsky I, Shellenbarger KC, Kalkwarf HJ. Age-related changes in appendicular lean mass in males with Duchenne muscular dystrophy: A retrospective review. Muscle Nerve. 2021 Feb;63(2):231-238. doi: 10.1002/mus.27107. Epub 2020 Dec 7.
- Background: PubMed 3601481Guzikowska E, Markiewicz-Loskot G, Hercog R. [Serum opsonization activity in children with recurrent respiratory tract infections]. Pediatr Pol. 1986 Dec;61(12):780-3. No abstract available. Polish.
- Background: PubMed 34936149Billich N, Evans M, Truby H, Ryan MM, Davidson ZE. The association between dietary factors and body weight and composition in boys with Duchenne muscular dystrophy. J Hum Nutr Diet. 2022 Oct;35(5):804-815. doi: 10.1111/jhn.12987. Epub 2022 Feb 1.
- Background: PubMed 38777460de Souza Costa AD, Vermeulen-Serpa KM, Batista Marinho KM, Carvalho Xavier de Medeiros CA, Antunes de Araujo A, Teixeira Dourado-Junior ME, Brandao-Neto J, Lima Maciel BL, Helena de Lima Vale S. Persistent inflammation and nutritional status in Duchenne muscular dystrophy. Clin Nutr ESPEN. 2024 Jun;61:393-398. doi: 10.1016/j.clnesp.2024.04.014. Epub 2024 Apr 20.
- Background: PubMed 33551221Chou E, Lindeback R, D'Silva AM, Sampaio H, Neville K, Farrar MA. Growth and nutrition in pediatric neuromuscular disorders. Clin Nutr. 2021 Jun;40(6):4341-4348. doi: 10.1016/j.clnu.2021.01.013. Epub 2021 Jan 22.
- Background: PubMed 24824013Davidson ZE, Ryan MM, Kornberg AJ, Sinclair K, Cairns A, Walker KZ, Truby H. Observations of body mass index in Duchenne muscular dystrophy: a longitudinal study. Eur J Clin Nutr. 2014 Aug;68(8):892-7. doi: 10.1038/ejcn.2014.93. Epub 2014 May 14.
- Background: PubMed 33602943Duan D, Goemans N, Takeda S, Mercuri E, Aartsma-Rus A. Duchenne muscular dystrophy. Nat Rev Dis Primers. 2021 Feb 18;7(1):13. doi: 10.1038/s41572-021-00248-3.
- Background: PubMed 32616572Garcia-Rodriguez R, Hiller M, Jimenez-Gracia L, van der Pal Z, Balog J, Adamzek K, Aartsma-Rus A, Spitali P. Premature termination codons in the DMD gene cause reduced local mRNA synthesis. Proc Natl Acad Sci U S A. 2020 Jul 14;117(28):16456-16464. doi: 10.1073/pnas.1910456117. Epub 2020 Jul 2.
- Background: PubMed 16770791Aartsma-Rus A, Van Deutekom JC, Fokkema IF, Van Ommen GJ, Den Dunnen JT. Entries in the Leiden Duchenne muscular dystrophy mutation database: an overview of mutation types and paradoxical cases that confirm the reading-frame rule. Muscle Nerve. 2006 Aug;34(2):135-44. doi: 10.1002/mus.20586.
- Background: PubMed 31789220Mercuri E, Bonnemann CG, Muntoni F. Muscular dystrophies. Lancet. 2019 Nov 30;394(10213):2025-2038. doi: 10.1016/S0140-6736(19)32910-1.
- Background: PubMed 25977513Davis J, Samuels E, Mullins L. Nutrition Considerations in Duchenne Muscular Dystrophy. Nutr Clin Pract. 2015 Aug;30(4):511-21. doi: 10.1177/0884533615586202. Epub 2015 May 14.
- Background: PubMed 30194761Bernabe-Garcia M, Rodriguez-Cruz M, Atilano S, Cruz-Guzman ODR, Almeida-Becerril T, Calder PC, Gonzalez J. Body composition and body mass index in Duchenne muscular dystrophy: Role of dietary intake. Muscle Nerve. 2019 Mar;59(3):295-302. doi: 10.1002/mus.26340. Epub 2018 Dec 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised dietary intervention in people with Duchenne Muscular Dystrophy (DMD), run by Ankara University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 21 Nov 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 Turkey (Türkiye). 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. 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?
Anthropometric measurements (time frame: From enrollment to the end of diet at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682585, which also lists 12 linked publications.
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 21 Nov 2025.