Type 1 Diabetes MellitusTN06NCT00333554
Nutritional Intervention to Prevent Diabetes
A study testing DHA Treatment in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 sites in United States.
Trial summary
Type 1 Diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases. Read more about this study
- Who is it for?
- Ages Up to 5 months
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- DHA Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 9 sitesUnited States
- Study dates
- Jun 2006to Apr 2013
- 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 Up to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pregnant mothers are eligible for enrollment into this study if they:
- Have T1D or the child's father, or a full or half-sibling of the child has T1D
- Are 18 years of age or older
- Are in their third trimester of pregnancy (i.e. gestation is 24 weeks or longer)
- Have understood and signed a written informed consent and HIPAA authorization
- Are willing to undergo randomization to ensure that equal numbers receive the DHA study substance versus the control
Show all 13Show fewer
- Infants are eligible for enrollment into this study if they:
- Are less than or equal to six months of age on the date of randomization
- Are found to be at risk for type 1 diabetes because they have a mother, father or full or half-sibling with T1D AND
- have a DR3 or DR4 allele OR
- have another relative (includes both 1st and 2nd degree relatives) with T1D (multiplex family)
- Have a parent or legal guardian who has understood and signed a written informed consent and HIPAA authorization
- Have a parent(s) or legal guardian(s) who are willing for their baby to undergo randomization to ensure that equal numbers receive the DHA study substance versus the control
Who cannot join
- Pregnant mothers are NOT eligible for enrollment into this study if they:
- Have any condition the investigator believes will put the mother or her fetus at an unacceptable medical risk for participation in this study
- Have a known complication of pregnancy causing an increased risk for the mother or fetus prior to entry into the study
- Have previously had multiple (2 or more) pre-term births (<36 weeks)
- Are diabetic and have a known HbA1c greater than 9% at anytime during the pregnancy (however, healthy infants after birth may qualify in spite of the above restrictions during pregnancy)
- Plan to take DHA supplementation during the study
Show all 12Show fewer
- Infants are NOT eligible for enrollment into this study if they:
- Have any condition the investigator believes will put the subject at an unacceptable medical risk for participation in this study
- Have a mother with a condition the investigator believes will put her at an unacceptable medical risk for participation in this study
- Have a nursing mother who plans to take DHA supplementation or has a parent or legal guardian who plans to provide supplementation to his/her infant independently during the study
- Have a protective allele (DQB1*0602 or DRB1*0403)
- Were born prior to 36 weeks gestation and require a pre-term infant formula
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Iowa Health Care
Iowa City, Iowa, 52242
The Children's Mercy Hospital
Kansas City, Missouri, 64108-9898
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
University of Minnesota
Minneapolis, Minnesota, 55455
Children's Hospital of Orange County
Orange, California, 92868-3835
Utah Diabetes Center
Salt Lake City, Utah, 84108
University of California, San Francisco
San Francisco, California, 94143
About this study
Type 1 Diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases.
The autoimmune process is thought to be initiated by a gene-environment interaction. The genetics involved in the development of T1D are fairly well understood. There is a higher risk of developing T1D with the presence of the human leukocyte antigen (HLA) DR3 or DR4. It is also known that not everyone with these genes actually develops T1D. Therefore, one or more environmental factors are thought to contribute to the process of developing T1D.
Read more
The consumption of the anti-inflammatory fatty acids, the omega-3 fatty acids, has decreased significantly in the past 100 years. At the same time a rise in the incidence of T1D, especially in young children has occurred. Because of the warnings to eliminate fish during pregnancy, pregnant women are consuming even less omega-3 fatty acids during fetal development.
Observations have been made that children who have received omega-3 fatty acid supplementation have a lower risk of T1D. Omega-3 fatty acids could have a protective effect that may occur during pregnancy, infancy, or both. The mechanism of this protection may be due to the DHA mediated suppression of the inflammatory response.
Patients at higher risk for T1D have an increased pro-inflammatory environment. We hypothesize that DHA supplementation during pregnancy and early childhood will block the initial pro-inflammatory events and prevent development of islet cell autoimmunity in children at higher risk for T1D.
This study is a feasibility study to determine if a full-scale DHA supplementation study will be implemented. If a full study is implemented, the primary outcome will be to determine if nutritional supplementation with omega-3 fatty acids during the last trimester of a mother's pregnancy and/or the first three years of life for children who are at higher risk of T1D will prevent the development of islet autoimmunity.
Read the detailed description
There are two possible entry pathways for study participants. The first pathway is the entry point for pregnant mothers in their third trimester (24 weeks gestational age) whose babies may be at higher risk for T1D based on family history. At birth, or soon after, their babies will be tested for HLA type (to look for the specific gene which confers a higher risk of developing T1D). If the HLA typing shows that the baby is at higher risk for T1D and no protective genes are present, the baby will then continue in the study. The second pathway is the entry point for babies whose mothers were not enrolled during pregnancy. These babies will also be tested for HLA type. Their eligibility will be based on the presence of higher risk genes or the presence of a multiplex family history. This screening process may take place up until the baby is 5 months old.
Eligible participants (pregnant women or infants) will be randomized to one of the two study groups: DHA (docosahexaenoic acid) study substance (this is the intervention) or control study substance (this is the placebo). The DHA (docosahexaenoic acid) to be used in this trial is produced from algae, not from fish oil, so there is no risk of mercury or pesticide contamination.
Pregnant and nursing mothers who are assigned to the control group will receive study capsules containing a vegetable oil and no DHA (docosahexaenoic acid) . Pregnant and nursing mothers who are assigned to the experimental group will receive study capsules containing DHA (docosahexaenoic acid) . During pregnancy and while breastfeeding, infants will receive the study substance indirectly through their mother (either the placenta or breastmilk).
Infants who are either partially or exclusively formula feeding will receive study substance more directly through the study formula. The control group will receive study formula containing the typical amount of DHA that can be found in some infant formulas, while infants in the experimental group will receive study formula containing a larger amount of DHA (docosahexaenoic acid) than typically found in some infant formulas. By six to twelve months of age, all infants will get study supplement added to solid foods.
All mothers will have contact with the study site every 3 months. Nursing mothers will provide samples of breast milk for fatty acids analysis at these visits.
Infants will need to come to follow-up study visits every 6 months. At each of these visits, the infant will have a limited physical exam and blood drawn from a vein to monitor immune activity, levels of fatty acid and vitamin D, and to check for diabetes-related autoantibodies. Infants/children cannot continue in the study if they: (1) develop two positive autoantibodies, present at two consecutive visits, or (2) develop T1D.
All follow-up study visits will continue for 1-2 years, and possibly an additional 2 years if a full-scale study is initiated.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- DHA Treatment, Placebo for DHA
- Keywords
- DHA, docosahexaenoic acid, omega-3 fatty acid, fish oil, pregnancy, infancy, prevention, "at risk" for developing type 1 diabetes, juvenile diabetes, T1D, diabetes mellitus, Type 1 diabetes TrialNet, TrialNet, dietary supplementation, nutrition
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA TreatmentDietary supplement
DHA study treatment given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food) depending on age of child.
Placebo for DHADietary supplement
Study placebo given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food)depending on age of child.
| Study group | Role | What they receive |
|---|---|---|
| DHA Treatment Group | Experimental | DHA study treatment given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food)depending on age of child. Receives: Dietary Supplement: DHA Treatment |
| Control Group | Placebo comparator | Placebo for DHA given to nursing mother (breast milk), study formula, or capsules (removing content and mixing with food)depending on age of child. Receives: Dietary Supplement: Placebo for DHA |
What is being measured
The primary outcome is the main question the study is designed to answer.
20% higher level of plasma and/or red blood cell membrane phospholipid DHA achieved in the treatment group
Measured: Every 3 months for two years; every 6 months until age 3.
At least a 20% reduction in the level of the major inflammatory cytokine, IL1-beta, achieved in the plasma of the treatment group
Measured: Every 3 months for two years; every 6 months until age 3.
Secondary outcomes (1)
95% of families will continue to attend follow-up visits
Measured: Every 3 months for two years; every 6 months until age 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2008
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jay S Skyler, M.D., Study chair, University of MiamiH. Peter Chase, MD, Principal investigator, The University of Colorado Health Science Center- Barbara Davis Center for Childhood DiabetesMichael Clare-Salzler, MD, Principal investigator, University of Florida, Department of Pathology, Department of Pediatrics, Diabetes Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333554
- Sponsor's protocol ID
- TN06 NIP
- Other IDs
- UC4DK097835
- Acronym
- TN06
- Status last verified
- Apr 2020
- First submitted
- 2 Jun 2006
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/tn06-nip-pilot/?query=tn06
Publications
Verge CF, Gianani R, Kawasaki E, Yu L, Pietropaolo M, Jackson RA, Chase HP, Eisenbarth GS. Prediction of type I diabetes in first-degree relatives using a combination of insulin, GAD, and ICA512bdc/IA-2 autoantibodies. Diabetes. 1996 Jul;45(7):926-33. doi: 10.2337/diab.45.7.926.
PubMed 8666144Karvonen M, Pitkaniemi J, Tuomilehto J. The onset age of type 1 diabetes in Finnish children has become younger. The Finnish Childhood Diabetes Registry Group. Diabetes Care. 1999 Jul;22(7):1066-70. doi: 10.2337/diacare.22.7.1066.
PubMed 10388969Rice R. Fish and healthy pregnancy: more than just a red herring! Prof Care Mother Child. 1996;6(6):171-3.
PubMed 9077255Stene LC, Joner G; Norwegian Childhood Diabetes Study Group. Use of cod liver oil during the first year of life is associated with lower risk of childhood-onset type 1 diabetes: a large, population-based, case-control study. Am J Clin Nutr. 2003 Dec;78(6):1128-34. doi: 10.1093/ajcn/78.6.1128.
PubMed 14668274Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, et al. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N Engl J Med. 1989 Feb 2;320(5):265-71. doi: 10.1056/NEJM198902023200501.
PubMed 2783477Simopoulos AP. Essential fatty acids in health and chronic disease. Am J Clin Nutr. 1999 Sep;70(3 Suppl):560S-569S. doi: 10.1093/ajcn/70.3.560s.
PubMed 10479232Chase HP, Cooper S, Osberg I, Stene LC, Barriga K, Norris J, Eisenbarth GS, Rewers M. Elevated C-reactive protein levels in the development of type 1 diabetes. Diabetes. 2004 Oct;53(10):2569-73. doi: 10.2337/diabetes.53.10.2569.
PubMed 15448085Friedberg CE, Janssen MJ, Heine RJ, Grobbee DE. Fish oil and glycemic control in diabetes. A meta-analysis. Diabetes Care. 1998 Apr;21(4):494-500. doi: 10.2337/diacare.21.4.494.
PubMed 9571330Chase HP, Boulware D, Rodriguez H, Donaldson D, Chritton S, Rafkin-Mervis L, Krischer J, Skyler JS, Clare-Salzler M; Type 1 Diabetes TrialNet Nutritional Intervention to Prevent (NIP) Type 1 Diabetes Study Group. Effect of docosahexaenoic acid supplementation on inflammatory cytokine levels in infants at high genetic risk for type 1 diabetes. Pediatr Diabetes. 2015 Jun;16(4):271-9. doi: 10.1111/pedi.12170. Epub 2014 Jul 12.
PubMed 25039804
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention to Prevent Diabetes
- ClinicalTrials.gov ID
- NCT00333554
- Acronym / sponsor ID
- TN06 / TN06 NIP
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- DHA, docosahexaenoic acid, omega-3 fatty acid, fish oil, pregnancy, infancy, prevention, "at risk" for developing type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jun 2006 (actual)
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Jun 2006 (estimated)
- 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.
Type 1 Diabetes (T1D) is an autoimmune disease. This means that the immune system (the part of the body which helps fight infections) mistakenly attacks and destroys the cells that produce insulin (islet cells found in the pancreas). As these cells are destroyed, the body's ability to produce insulin decreases.
The autoimmune process is thought to be initiated by a gene-environment interaction. The genetics involved in the development of T1D are fairly well understood. There is a higher risk of developing T1D with the presence of the human leukocyte antigen (HLA) DR3 or DR4. It is also known that not everyone with these genes actually develops T1D. Therefore, one or more environmental factors are thought to contribute to the process of developing T1D.
The consumption of the anti-inflammatory fatty acids, the omega-3 fatty acids, has decreased significantly in the past 100 years. At the same time a rise in the incidence of T1D, especially in young children has occurred. Because of the warnings to eliminate fish during pregnancy, pregnant women are consuming even less omega-3 fatty acids during fetal development.
Observations have been made that children who have received omega-3 fatty acid supplementation have a lower risk of T1D. Omega-3 fatty acids could have a protective effect that may occur during pregnancy, infancy, or both. The mechanism of this protection may be due to the DHA mediated suppression of the inflammatory response.
Patients at higher risk for T1D have an increased pro-inflammatory environment. We hypothesize that DHA supplementation during pregnancy and early childhood will block the initial pro-inflammatory events and prevent development of islet cell autoimmunity in children at higher risk for T1D.
This study is a feasibility study to determine if a full-scale DHA supplementation study will be implemented. If a full study is implemented, the primary outcome will be to determine if nutritional supplementation with omega-3 fatty acids during the last trimester of a mother's pregnancy and/or the first three years of life for children who are at higher risk of T1D will prevent the development of islet autoimmunity.
Detailed description
There are two possible entry pathways for study participants. The first pathway is the entry point for pregnant mothers in their third trimester (24 weeks gestational age) whose babies may be at higher risk for T1D based on family history. At birth, or soon after, their babies will be tested for HLA type (to look for the specific gene which confers a higher risk of developing T1D). If the HLA typing shows that the baby is at higher risk for T1D and no protective genes are present, the baby will then continue in the study. The second pathway is the entry point for babies whose mothers were not enrolled during pregnancy. These babies will also be tested for HLA type. Their eligibility will be based on the presence of higher risk genes or the presence of a multiplex family history. This screening process may take place up until the baby is 5 months old.
Eligible participants (pregnant women or infants) will be randomized to one of the two study groups: DHA (docosahexaenoic acid) study substance (this is the intervention) or control study substance (this is the placebo). The DHA (docosahexaenoic acid) to be used in this trial is produced from algae, not from fish oil, so there is no risk of mercury or pesticide contamination.
Pregnant and nursing mothers who are assigned to the control group will receive study capsules containing a vegetable oil and no DHA (docosahexaenoic acid) . Pregnant and nursing mothers who are assigned to the experimental group will receive study capsules containing DHA (docosahexaenoic acid) . During pregnancy and while breastfeeding, infants will receive the study substance indirectly through their mother (either the placenta or breastmilk).
Infants who are either partially or exclusively formula feeding will receive study substance more directly through the study formula. The control group will receive study formula containing the typical amount of DHA that can be found in some infant formulas, while infants in the experimental group will receive study formula containing a larger amount of DHA (docosahexaenoic acid) than typically found in some infant formulas. By six to twelve months of age, all infants will get study supplement added to solid foods.
All mothers will have contact with the study site every 3 months. Nursing mothers will provide samples of breast milk for fatty acids analysis at these visits.
Infants will need to come to follow-up study visits every 6 months. At each of these visits, the infant will have a limited physical exam and blood drawn from a vein to monitor immune activity, levels of fatty acid and vitamin D, and to check for diabetes-related autoantibodies. Infants/children cannot continue in the study if they: (1) develop two positive autoantibodies, present at two consecutive visits, or (2) develop T1D.
All follow-up study visits will continue for 1-2 years, and possibly an additional 2 years if a full-scale study is initiated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA Treatment Group | Experimental | Dietary Supplement: DHA TreatmentDHA study treatment given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food)depending on age of child. |
| Control Group | Placebo comparator | Dietary Supplement: Placebo for DHAPlacebo for DHA given to nursing mother (breast milk), study formula, or capsules (removing content and mixing with food)depending on age of child. |
Who may qualify
- Ages
- Up to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Have T1D or the child's father, or a full or half-sibling of the child has T1D
- Are 18 years of age or older
- Are in their third trimester of pregnancy (i.e. gestation is 24 weeks or longer)
- Have understood and signed a written informed consent and HIPAA authorization
- Are willing to undergo randomization to ensure that equal numbers receive the DHA study substance versus the control
Key exclusion criteria (12 listed)
- Have any condition the investigator believes will put the mother or her fetus at an unacceptable medical risk for participation in this study
- Have a known complication of pregnancy causing an increased risk for the mother or fetus prior to entry into the study
- Have previously had multiple (2 or more) pre-term births (<36 weeks)
- Are diabetic and have a known HbA1c greater than 9% at anytime during the pregnancy (however, healthy infants after birth may qualify in spite of the above restrictions during pregnancy)
- Plan to take DHA supplementation during the study
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 |
|---|---|---|
| DHA TreatmentDHA study treatment given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food) depending on age of child. | Dietary supplement | DHA Treatment Group |
| Placebo for DHAStudy placebo given on daily basis to nursing mother (breast milk) or baby as either formula, or capsules (removing content and mixing with food)depending on age of child. | Dietary supplement | Control Group |
Primary outcome
20% higher level of plasma and/or red blood cell membrane phospholipid DHA achieved in the treatment group
Time frame: Every 3 months for two years; every 6 months until age 3.
At least a 20% reduction in the level of the major inflammatory cytokine, IL1-beta, achieved in the plasma of the treatment group
Time frame: Every 3 months for two years; every 6 months until age 3.
1 secondary outcome
95% of families will continue to attend follow-up visits
Time frame: Every 3 months for two years; every 6 months until age 3.
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 29 Apr 2020.
- Background: PubMed 8666144Verge CF, Gianani R, Kawasaki E, Yu L, Pietropaolo M, Jackson RA, Chase HP, Eisenbarth GS. Prediction of type I diabetes in first-degree relatives using a combination of insulin, GAD, and ICA512bdc/IA-2 autoantibodies. Diabetes. 1996 Jul;45(7):926-33. doi: 10.2337/diab.45.7.926.
- Background: PubMed 10388969Karvonen M, Pitkaniemi J, Tuomilehto J. The onset age of type 1 diabetes in Finnish children has become younger. The Finnish Childhood Diabetes Registry Group. Diabetes Care. 1999 Jul;22(7):1066-70. doi: 10.2337/diacare.22.7.1066.
- Background: PubMed 9077255Rice R. Fish and healthy pregnancy: more than just a red herring! Prof Care Mother Child. 1996;6(6):171-3.
- Background: PubMed 14668274Stene LC, Joner G; Norwegian Childhood Diabetes Study Group. Use of cod liver oil during the first year of life is associated with lower risk of childhood-onset type 1 diabetes: a large, population-based, case-control study. Am J Clin Nutr. 2003 Dec;78(6):1128-34. doi: 10.1093/ajcn/78.6.1128.
- Background: PubMed 2783477Endres S, Ghorbani R, Kelley VE, Georgilis K, Lonnemann G, van der Meer JW, Cannon JG, Rogers TS, Klempner MS, Weber PC, et al. The effect of dietary supplementation with n-3 polyunsaturated fatty acids on the synthesis of interleukin-1 and tumor necrosis factor by mononuclear cells. N Engl J Med. 1989 Feb 2;320(5):265-71. doi: 10.1056/NEJM198902023200501.
- Background: PubMed 10479232Simopoulos AP. Essential fatty acids in health and chronic disease. Am J Clin Nutr. 1999 Sep;70(3 Suppl):560S-569S. doi: 10.1093/ajcn/70.3.560s.
- Background: PubMed 15448085Chase HP, Cooper S, Osberg I, Stene LC, Barriga K, Norris J, Eisenbarth GS, Rewers M. Elevated C-reactive protein levels in the development of type 1 diabetes. Diabetes. 2004 Oct;53(10):2569-73. doi: 10.2337/diabetes.53.10.2569.
- Background: PubMed 9571330Friedberg CE, Janssen MJ, Heine RJ, Grobbee DE. Fish oil and glycemic control in diabetes. A meta-analysis. Diabetes Care. 1998 Apr;21(4):494-500. doi: 10.2337/diacare.21.4.494.
- Results publication: PubMed 25039804Chase HP, Boulware D, Rodriguez H, Donaldson D, Chritton S, Rafkin-Mervis L, Krischer J, Skyler JS, Clare-Salzler M; Type 1 Diabetes TrialNet Nutritional Intervention to Prevent (NIP) Type 1 Diabetes Study Group. Effect of docosahexaenoic acid supplementation on inflammatory cytokine levels in infants at high genetic risk for type 1 diabetes. Pediatr Diabetes. 2015 Jun;16(4):271-9. doi: 10.1111/pedi.12170. Epub 2014 Jul 12.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/tn06-nip-pilot/?query=tn06
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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.
Jay S Skyler, M.D. study chair
University of Miami
H. Peter Chase, MD principal investigator
The University of Colorado Health Science Center- Barbara Davis Center for Childhood Diabetes
Michael Clare-Salzler, MD principal investigator
University of Florida, Department of Pathology, Department of Pediatrics, Diabetes Research Program
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA Treatment in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 sites in United States.
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 13 inclusion and 12 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
20% higher level of plasma and/or red blood cell membrane phospholipid DHA achieved in the treatment group (time frame: Every 3 months for two years; every 6 months until age 3.). 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?
On the ClinicalTrials.gov record for NCT00333554, which also lists 9 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 29 Apr 2020.