Beta-cell AutoimmunityFINDIANCT01055080
Insulin-free Cow Milk Formula in Prevention of Type 1 Diabetes Associated Autoimmunity - FINDIA Pilot Study
A study testing Cow's milk formula in people with Beta-cell Autoimmunity, run by Finnish Institute for Health and Welfare.
Trial summary
The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Beta-cell Autoimmunity
- What is being tested?
- Cow's milk formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 987 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Dec 2009
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HLA-conferred genetic susceptibility for type 1 diabetes
Who cannot join
- Pre-term, maternal diabetes with insulin treatment
About this study
Official title: Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.
- Conditions
- Beta-cell Autoimmunity
- Being tested
- Cow's milk formula
- Keywords
- type 1 diabetes, beta-cell autoantibodies, cow's milk formula, bovine insulin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow's milk formulaDietary supplement
Weaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life
| Study group | Role | What they receive |
|---|---|---|
| Cow's milk formula | Placebo comparator | Not described Receives: Dietary Supplement: Cow's milk formula |
| Bovine insulin-free whey based formula | Active comparator | Not described Receives: Dietary Supplement: Cow's milk formula |
| Whey-based hydrolysed formula | Active comparator | Not described Receives: Dietary Supplement: Cow's milk formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-cell autoantibodies
Measured: 3,6,12,24,36,48,60,72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startMay 2002
- Primary completionJun 2006
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Beta-cell AutoimmunityStudies 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
- 987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Valio Ltd, University of Turku, University of Helsinki, University of Eastern Finland
- Investigators
- Outi Vaarala, MD PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055080
- Sponsor's protocol ID
- FINDIA2002
- Acronym
- FINDIA
- Status last verified
- Jan 2010
- First submitted
- 22 Jan 2010
- Last updated
- 25 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
de Goffau MC, Luopajarvi K, Knip M, Ilonen J, Ruohtula T, Harkonen T, Orivuori L, Hakala S, Welling GW, Harmsen HJ, Vaarala O. Fecal microbiota composition differs between children with beta-cell autoimmunity and those without. Diabetes. 2013 Apr;62(4):1238-44. doi: 10.2337/db12-0526. Epub 2012 Dec 28.
PubMed 23274889Vaarala O, Ilonen J, Ruohtula T, Pesola J, Virtanen SM, Harkonen T, Koski M, Kallioinen H, Tossavainen O, Poussa T, Jarvenpaa AL, Komulainen J, Lounamaa R, Akerblom HK, Knip M. Removal of Bovine Insulin From Cow's Milk Formula and Early Initiation of Beta-Cell Autoimmunity in the FINDIA Pilot Study. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):608-14. doi: 10.1001/archpediatrics.2011.1559.
PubMed 22393174
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Dietary Prevention of Type 1 Diabetes Associated Beta-cell Autoimmunity in Children at Genetic Risk
- ClinicalTrials.gov ID
- NCT01055080
- Acronym / sponsor ID
- FINDIA / FINDIA2002
- Conditions
- Beta-cell Autoimmunity
- Keywords
- type 1 diabetes, beta-cell autoantibodies, cow's milk formula, bovine insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 987 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Valio Ltd, University of Turku, University of Helsinki, University of Eastern Finland
- Study start
- May 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jan 2010 (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.
The purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based FINDIA formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cow's milk formula | Placebo comparator | Dietary Supplement: Cow's milk formula |
| Bovine insulin-free whey based formula | Active comparator | Dietary Supplement: Cow's milk formula |
| Whey-based hydrolysed formula | Active comparator | Dietary Supplement: Cow's milk formula |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HLA-conferred genetic susceptibility for type 1 diabetes
Key exclusion criteria (1 listed)
- Pre-term, maternal diabetes with insulin treatment
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 |
|---|---|---|
| Cow's milk formulaWeaning to three different type of cow's milk formula when breast milk is not available during the first 6 months of life | Dietary supplement | Bovine insulin-free whey based formula, Cow's milk formula, Whey-based hydrolysed formula |
Primary outcome
Beta-cell autoantibodies
Time frame: 3,6,12,24,36,48,60,72 months
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 25 Jan 2010.
- Derived from this study: PubMed 23274889de Goffau MC, Luopajarvi K, Knip M, Ilonen J, Ruohtula T, Harkonen T, Orivuori L, Hakala S, Welling GW, Harmsen HJ, Vaarala O. Fecal microbiota composition differs between children with beta-cell autoimmunity and those without. Diabetes. 2013 Apr;62(4):1238-44. doi: 10.2337/db12-0526. Epub 2012 Dec 28.
- Derived from this study: PubMed 22393174Vaarala O, Ilonen J, Ruohtula T, Pesola J, Virtanen SM, Harkonen T, Koski M, Kallioinen H, Tossavainen O, Poussa T, Jarvenpaa AL, Komulainen J, Lounamaa R, Akerblom HK, Knip M. Removal of Bovine Insulin From Cow's Milk Formula and Early Initiation of Beta-Cell Autoimmunity in the FINDIA Pilot Study. Arch Pediatr Adolesc Med. 2012 Jul 1;166(7):608-14. doi: 10.1001/archpediatrics.2011.1559.
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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.
Outi Vaarala, MD PhD principal investigator
Finnish Institute for Health and Welfare
Questions about this trial
What is this clinical trial studying?
A study testing Cow's milk formula in people with Beta-cell Autoimmunity, run by Finnish Institute for Health and Welfare.
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 25 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Beta-cell autoantibodies (time frame: 3,6,12,24,36,48,60,72 months). 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 NCT01055080, which also lists 2 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 25 Jan 2010.