Muscular Dystrophy, DuchenneNCT01826422

Effect of EPA and DHA in the Inflammation and Metabolic Disorders in DMD/DMB Patients

A study testing EPA and DHA in people with Muscular Dystrophy, Duchenne, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effect of docosahexaenoic fatty acid and eicosapentaenoic fatty acid supplementation for six months on the inflammation state as well as the process of muscular regeneration and the metabolic disorders like obesity and insulin resistance in patients with Duchenne muscular… Read more about this study

Who is it for?: Ages 6 to 18 years, men only
Conditions the study is for: Muscular Dystrophy, Duchenne
What is being tested?: EPA and DHA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteMexico
Study dates: Mar 2013to Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 18 years
Men only
No healthy volunteers
Child, Adult

Who may be able to join

Written informed consent and assent by the patient and both parents or guardian.
Patients with clinical diagnosis of Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (DMB)
Patients were not under treatment with corticosteroids

Who cannot join

Patients decided to withdraw from the study
Consumption of dietary supplements containing polyunsaturated fatty acids omega 3.
With hypersensitivity to fish oil.
Patients with respiratory and gastrointestinal problems. Medical responsible assessment the presence of respiratory and gastrointestinal problems.
Patients with difficulty swallowing food, including those who have the difficulty ingesting oil capsules.
Gastrostomy fed patients.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Unit of Medical Researcha in Nutrition, Pediatric Hospital, IMSS.
Mexico City, 06720

Other trials in Mexico

About this study

Official title: Effect of Eicosapentaenoic Fatty Acid (EPA) and Docosahexaenoic Fatty Acids (DHA) Supplementation on the Inflammation State and Metabolic Disorders in Patients With Duchenne Muscular Dystrophy or Becker Muscular Dystrophy

Read the detailed description

DMD and DMB are X-linked diseases caused by mutations in the DMD gene, these mutations have important functional and structural consequences in skeletal muscle. In muscle fiber is observed inflammation and necrosis as a result of lost regenerative capacity. The muscle fibers can be replaced by connective and adipose tissue. In a previous study the investigators identified that 50% of Duchenne and Becker patients in the range of thirteen years old have obesity. In addition, these patients (N=66) have hyperinsulinemia (53.7%) and insulin resistance (48.5%). It is well known that obesity, hyperinsulinemia and insulin resistance have a inflammatory background.

It has been demonstrated that eicosapentaenoic fatty acid (EPA) and docosahexaenoic fatty acid (DHA) exhibit anti-inflammatory properties and have beneficial effects on obesity, hyperinsulinemia and insulin resistance in children and adolescents.

Objective: Determine the effect of EPA and DHA on inflammation, obesity and insulin resistance in patients with DMD/DMB compared to those receiving placebo.

Conditions: Muscular Dystrophy, Duchenne
Being tested: EPA and DHA, Placebo Comparator
Keywords: Muscular Dystrophy, Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Omega 3, Eicosapentaenoic fatty acid, Docosahexaenoic fatty acid
Medical subject headings: Muscular Dystrophy, Duchenne, Muscular Dystrophies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EPA and DHADietary supplement
Also called omega 3 fatty acid
Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.
Placebo ComparatorDietary supplement
Placebo capsules will contain gelatin and sunflower oil. Fatty acid composition is as follows: lauric (C12:0), 0.19%; myristic (C14:0), 0.29%; palmitic (C16:0), 7.59%; palmitoleic (C16:1), 0.25%; stearic (C18:0), 3.49%; oleic (C18:1), 31.08%; linolenic (C18:3), 1.13%; linoleic (C18:2), 55.64%; DHA 0.02%; arachidic (C20:0), 0.30% and arachidonic (C20:4), 0.01%.

Study groups in NCT01826422
Study group	Role	What they receive
EPA and DHA	Experimental	Supplementation of 2.7 g/d of EPA and DHA were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes were specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade. Receives: Dietary Supplement: EPA and DHA
Placebo Comparator	Placebo comparator	Supplementation of placebo with sunflower fatty at doses of 2.7 g/d were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil, so, it did not present anti-inflammatory or insulin sensitivity effects. Receives: Dietary Supplement: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Composition (Body Fat)
We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).
Measured: At baseline and at months 3 and 6 of supplementation.
Lean Mass
We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).
Measured: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Anthropometric Measurement: Body Mass Index
We measured weight, height by anthropometric to calculate the body mass index (body mass index).
Measured: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Glucose in Serum
A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.
Measured: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Insulin in Blood
A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).
Measured: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.

Secondary outcomes (15)

Inflammation Biomarkers (TNF-A)
Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarkers (IL-1)
Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarkers (IL-6)
Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Measured: Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.
Inflammation Biomarkers (IL-10)
Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (IL-6 Expression)
The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR).
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (TNF-A Expression)
The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR)
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (IL-1 Expression)
The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR).
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (Creatinine Kinase)
The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L.
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (MMP9)
Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL.
Measured: Time Frame: At baseline and at months 1, 2, 3 of supplementation.
Markers of Muscle Degeneration (sFas)
The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (Receptor of Fas)
The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Measured: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Regeneration (VEGF)
Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA).
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Regeneration (FGF)
Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.
Measured: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Incorporation of DHA in the Erythrocytes
The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography.
Measured: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Incorporation of EPA in the Erythrocytes
The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography.
Measured: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jan 2017

First posted8 Apr 2013 (estimated)
Study startMar 2013
Primary completionJan 2017
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Muscular Dystrophy, DuchenneStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01826422
Sponsor's protocol ID: DHA/EPA in Dunchenne
Other IDs: 180058
Status last verified: Feb 2018
First submitted: 4 Apr 2013
Last updated: 9 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Cruz Guzman Odel R, Chavez Garcia AL, Rodriguez-Cruz M. Muscular dystrophies at different ages: metabolic and endocrine alterations. Int J Endocrinol. 2012;2012:485376. doi: 10.1155/2012/485376. Epub 2012 Jun 3.
PubMed 22701119
Rodriguez-Cruz M, Sanchez R, Escobar RE, Cruz-Guzman Odel R, Lopez-Alarcon M, Bernabe Garcia M, Coral-Vazquez R, Matute G, Velazquez Wong AC. Evidence of Insulin Resistance and Other Metabolic Alterations in Boys with Duchenne or Becker Muscular Dystrophy. Int J Endocrinol. 2015;2015:867273. doi: 10.1155/2015/867273. Epub 2015 May 19.
PubMed 26089900
Rodriguez-Cruz M, Cruz-Guzman ODR, Almeida-Becerril T, Solis-Serna AD, Atilano-Miguel S, Sanchez-Gonzalez JR, Barbosa-Cortes L, Ruiz-Cruz ED, Huicochea JC, Cardenas-Conejo A, Escobar-Cedillo RE, Yam-Ontiveros CA, Ricardez-Marcial EF. Potential therapeutic impact of omega-3 long chain-polyunsaturated fatty acids on inflammation markers in Duchenne muscular dystrophy: A double-blind, controlled randomized trial. Clin Nutr. 2018 Dec;37(6 Pt A):1840-1851. doi: 10.1016/j.clnu.2017.09.011. Epub 2017 Sep 23.
PubMed 28987470
Villaldama-Soriano MA, Rodriguez-Cruz M, Hernandez-De la Cruz SY, Almeida-Becerril T, Cardenas-Conejo A, Wong-Baeza C. Pro-inflammatory monocytes are increased in Duchenne muscular dystrophy and suppressed with omega-3 fatty acids: A double-blind, randomized, placebo-controlled pilot study. Eur J Neurol. 2022 Mar;29(3):855-864. doi: 10.1111/ene.15184. Epub 2021 Nov 26.
PubMed 34779542
Rodriguez-Cruz M, Atilano-Miguel S, Barbosa-Cortes L, Bernabe-Garcia M, Almeida-Becerril T, Cardenas-Conejo A, Del Rocio Cruz-Guzman O, Maldonado-Hernandez J. Evidence of muscle loss delay and improvement of hyperinsulinemia and insulin resistance in Duchenne muscular dystrophy supplemented with omega-3 fatty acids: A randomized study. Clin Nutr. 2019 Oct;38(5):2087-2097. doi: 10.1016/j.clnu.2018.10.017. Epub 2018 Oct 30.
PubMed 30420291

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Multimodal Study About Absence of Dp140 in Becker Muscular Dystrophy: Brain-muscle Imaging, Cognition and Muscle Function
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All Muscular Dystrophy, Duchenne trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Eicosapentaenoic Fatty Acid (EPA) and Docosahexaenoic Fatty Acids (DHA) Supplementation on the Inflammation State and Metabolic Disorders in Patients With Duchenne Muscular Dystrophy or Becker Muscular Dystrophy
ClinicalTrials.gov ID: NCT01826422
Acronym / sponsor ID: DHA/EPA in Dunchenne
Conditions: Muscular Dystrophy, Duchenne
Keywords: Muscular Dystrophy, Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, Omega 3, Eicosapentaenoic fatty acid, Docosahexaenoic fatty acid
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Coordinación de Investigación en Salud, MexicoOther government
Collaborators: Instituto Nacional de Rehabilitacion
Study start: Mar 2013
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 8 Apr 2013 (estimated)
Results: Posted 1 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective: Determine the effect of EPA and DHA on inflammation, obesity and insulin resistance in patients with DMD/DMB compared to those receiving placebo.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EPA and DHA	Experimental	Dietary Supplement: EPA and DHASupplementation of 2.7 g/d of EPA and DHA were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes were specially for children to improved the feeding process and its presentation is in gelatin capsules. The supplement is purified fish oil with pharmaceutical grade.
Placebo Comparator	Placebo comparator	Dietary Supplement: Placebo ComparatorSupplementation of placebo with sunflower fatty at doses of 2.7 g/d were provided in 10 capsules per day (4 in the morning, 3 in the afternoon and 3 at night) during a period of 6 months. The capsules sizes are specially for children to improved the feeding process. This placebo is sunflower oil, so, it did not present anti-inflammatory or insulin sensitivity effects.

Who may qualify

Ages: 6 to 18 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

Written informed consent and assent by the patient and both parents or guardian.
Patients with clinical diagnosis of Duchenne Muscular Dystrophy (DMD) or Becker Muscular Dystrophy (DMB)
Patients were not under treatment with corticosteroids

Key exclusion criteria (6 listed)

Patients decided to withdraw from the study
Consumption of dietary supplements containing polyunsaturated fatty acids omega 3.
With hypersensitivity to fish oil.
Patients with respiratory and gastrointestinal problems. Medical responsible assessment the presence of respiratory and gastrointestinal problems.
Patients with difficulty swallowing food, including those who have the difficulty ingesting oil capsules.

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
EPA and DHAAlso: omega 3 fatty acidEach capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.	Dietary supplement	EPA and DHA
Placebo ComparatorPlacebo capsules will contain gelatin and sunflower oil. Fatty acid composition is as follows: lauric (C12:0), 0.19%; myristic (C14:0), 0.29%; palmitic (C16:0), 7.59%; palmitoleic (C16:1), 0.25%; stearic (C18:0), 3.49%; oleic (C18:1), 31.08%; linolenic (C18:3), 1.13%; linoleic (C18:2), 55.64%; DHA 0.02%; arachidic (C20:0), 0.30% and arachidonic (C20:4), 0.01%.	Dietary supplement	Placebo Comparator

Primary outcome

Body Composition (Body Fat)
Time frame: At baseline and at months 3 and 6 of supplementation.
We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).
Lean Mass
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).
Anthropometric Measurement: Body Mass Index
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
We measured weight, height by anthropometric to calculate the body mass index (body mass index).
Glucose in Serum
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.
Insulin in Blood
Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).

15 secondary outcomes

Inflammation Biomarkers (TNF-A)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarkers (IL-1)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarkers (IL-6)
Time frame: Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.
Inflammation Biomarkers (IL-10)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (IL-6 Expression)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (TNF-A Expression)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Inflammation Biomarker (IL-1 Expression)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (Creatinine Kinase)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (MMP9)
Time frame: Time Frame: At baseline and at months 1, 2, 3 of supplementation.
Markers of Muscle Degeneration (sFas)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Degeneration (Receptor of Fas)
Time frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Regeneration (VEGF)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Markers of Muscle Regeneration (FGF)
Time frame: Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.
Incorporation of DHA in the Erythrocytes
Time frame: Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.
Incorporation of EPA in the Erythrocytes
Time frame: Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6

Results and safety

Results posted to the registry on 1 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EPA and DHA	18	17
Sunflower Oil	22	19

Primary outcome: Body Composition (Body Fat)

Time frame: At baseline and at months 3 and 6 of supplementation.. Median (Full Range). Unit: g/Kg of body weight

Measure	EPA and DHA n = 17	Sunflower Oil n = 19
Basal	172.1 (84.7 to 530.4)	232.7 (122.5 to 542.0)
Month 3 after supplement	180.2 (95.2 to 540.2)	274.8 (124.4 to 547.3)
Month 6 after supplement	181.9 (98.0 to 535.0)	298.2 (120.7 to 567.2)

EPA and DHA vs Sunflower Oil: p <0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Lean Mass

Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.. Mean (Full Range). Unit: g/kg of body weight

Measure	EPA and DHA n = 17	Sunflower Oil n = 19
Basal	774.7 (429.1 to 857.3)	662.4 (413.3 to 841.4)
Month 1 after supplement	769.6 (427.0 to 846.0)	647.7 (420.4 to 827.6)
Month 2 after supplement	772.4 (419.9 to 851.5)	630.6 (420.1 to 827.4)
Month 3 after supplement	757.7 (421.0 to 838.7)	627.7 (414.5 to 835.2)
Month 4 after supplement	755.7 (416.9 to 855.0)	605.7 (414.0 to 823.6)
Month 5 after supplement	768.6 (423.6 to 829.8)	617.7 (433.0 to 811.6)
Month 6 after supplement	766.7 (426.2 to 849.9)	606.2 (398.1 to 813.1)

EPA and DHA vs Sunflower Oil: p >0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Anthropometric Measurement: Body Mass Index

Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.. Median (Full Range). Unit: g/m^2

Measure	EPA and DHA n = 17	Sunflower Oil n = 19
Basal	42.5 (20.4 to 97.0)	72.7 (1.8 to 98.4)
Month 1 after supplement	48.2 (9.6 to 97.2)	78.3 (3.9 to 98.7)
Month 2 after supplement	49.6 (3.7 to 97.6)	83.2 (5.4 to 98.5)
Month 3 after supplement	47.4 (15.3 to 97.2)	82.2 (4.8 to 97.7)
Month 4 after supplement	49.9 (14.8 to 95.9)	73.7 (9.8 to 98.0)
Month 5 after supplement	47.4 (3.4 to 96.5)	75.3 (7.7 to 98.1)
Month 6 after supplement	51.7 (9.5 to 96.8)	73.6 (5.3 to 98.2)

EPA and DHA vs Sunflower Oil: p >0.05, Wilcoxon (Mann-Whitney)

Primary outcome: Glucose in Serum

Time frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.. Median (Full Range). Unit: mg/dL

Measure	EPA and DHA n = 17	Sunflower Oil n = 19
Basal	83.5 (77.0 to 98.0)	89.0 (76.0 to 121.0)
Month 1 after supplement	84.5 (79.0 to 98.0)	90.0 (81.0 to 98.0)
Month 2 after supplement	87.5 (74.0 to 93.0)	89.0 (79.0 to 107.0)
Month 3 after supplement	84.0 (61.0 to 95.0)	86.8 (79.5 to 99.0)
Month 4 after supplement	83.0 (72.0 to 97.0)	87.0 (82.0 to 107.0)
Month 5 after supplement	84.0 (76.0 to 99.0)	89.8 (75.0 to 99.0)
Month 6 after supplement	82.0 (76.0 to 98.0)	88.0 (78.0 to 99.0)

EPA and DHA vs Sunflower Oil: p <0.05, Wilcoxon (Mann-Whitney)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: One patient presented vomiting and diarrhea, the patient had three evacuations during the night in a period of 3 hours and vomiting occurred for a period of 10 minutes. These complications occurred only once in the first month of supplementation.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EPA and DHA	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18
Sunflower Oil	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Limitations and caveats (from the sponsor): Limitations: The sample size was not completed mainly because patients were not eligible for inclusion. It was not possible to standardize the technical procedures for DNA fragmentation evaluation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22701119Cruz Guzman Odel R, Chavez Garcia AL, Rodriguez-Cruz M. Muscular dystrophies at different ages: metabolic and endocrine alterations. Int J Endocrinol. 2012;2012:485376. doi: 10.1155/2012/485376. Epub 2012 Jun 3.
Background: PubMed 26089900Rodriguez-Cruz M, Sanchez R, Escobar RE, Cruz-Guzman Odel R, Lopez-Alarcon M, Bernabe Garcia M, Coral-Vazquez R, Matute G, Velazquez Wong AC. Evidence of Insulin Resistance and Other Metabolic Alterations in Boys with Duchenne or Becker Muscular Dystrophy. Int J Endocrinol. 2015;2015:867273. doi: 10.1155/2015/867273. Epub 2015 May 19.
Results publication: PubMed 28987470Rodriguez-Cruz M, Cruz-Guzman ODR, Almeida-Becerril T, Solis-Serna AD, Atilano-Miguel S, Sanchez-Gonzalez JR, Barbosa-Cortes L, Ruiz-Cruz ED, Huicochea JC, Cardenas-Conejo A, Escobar-Cedillo RE, Yam-Ontiveros CA, Ricardez-Marcial EF. Potential therapeutic impact of omega-3 long chain-polyunsaturated fatty acids on inflammation markers in Duchenne muscular dystrophy: A double-blind, controlled randomized trial. Clin Nutr. 2018 Dec;37(6 Pt A):1840-1851. doi: 10.1016/j.clnu.2017.09.011. Epub 2017 Sep 23.
Derived from this study: PubMed 34779542Villaldama-Soriano MA, Rodriguez-Cruz M, Hernandez-De la Cruz SY, Almeida-Becerril T, Cardenas-Conejo A, Wong-Baeza C. Pro-inflammatory monocytes are increased in Duchenne muscular dystrophy and suppressed with omega-3 fatty acids: A double-blind, randomized, placebo-controlled pilot study. Eur J Neurol. 2022 Mar;29(3):855-864. doi: 10.1111/ene.15184. Epub 2021 Nov 26.
Derived from this study: PubMed 30420291Rodriguez-Cruz M, Atilano-Miguel S, Barbosa-Cortes L, Bernabe-Garcia M, Almeida-Becerril T, Cardenas-Conejo A, Del Rocio Cruz-Guzman O, Maldonado-Hernandez J. Evidence of muscle loss delay and improvement of hyperinsulinemia and insulin resistance in Duchenne muscular dystrophy supplemented with omega-3 fatty acids: A randomized study. Clin Nutr. 2019 Oct;38(5):2087-2097. doi: 10.1016/j.clnu.2018.10.017. Epub 2018 Oct 30.
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.

Maricela Rodriguez-Cruz, PhD principal investigator

Instituto Mexicano del Seguro Social

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EPA and DHA in people with Muscular Dystrophy, Duchenne, run by Coordinación de Investigación en Salud, Mexico 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 3 inclusion and 6 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 9 Mar 2018. 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?

Yes. Results are posted in the registry (first posted 1 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Body Composition (Body Fat) (time frame: At baseline and at months 3 and 6 of supplementation.). The study lists 5 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 NCT01826422, which also lists 5 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 9 Mar 2018.