Atopic DermatitisNCT01936194
The Effects of Polyunsaturated Fatty Acids (PUFA) on Allergic/Atopic Dermatitis
A study testing DHA+EPA, High Olive Oil and DHA in people with Atopic Dermatitis, run by Mead Johnson Nutrition at 1 site in China.
Trial summary
This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- DHA+EPA, High Olive Oil and DHA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Nov 2014
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Woman is pregnant between 16 and 20 weeks
- Mother delivers after 36 weeks
- Mother is willing to breast-feed for four months
- Mother has potential to deliver a child with increased risk of atopic dermatitis
- Signed Informed Consent
Who cannot join
- Mother is smoking
- Disease with influence on breast feeding
- Complicated pregnancy
- Allergic to seafood
- Allergic to soy
- Allergic to marine fish
- Mother has more than two salmon or tuna meals per week
- Mother is undergoing treatment with anticoagulants
Trial locations and contacts
1 site in 1 country.
China1 site
International Peace Maternity and Child Health Hospital of China welfare Institute
Shanghai, Shanghai Municipality, 200030
About this study
Official title: The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis
This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.
- Conditions
- Atopic Dermatitis
- Being tested
- DHA+EPA, High Olive Oil, DHA
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA+EPADietary supplement
High Olive OilDietary supplement
DHADietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Docosahexaenoic Acid (DHA) | Experimental | infants receiving capsule containing DHA. Receives: Dietary Supplement: DHA |
| High Olive Oil | Other | infants receiving capsule without DHA and EPA. Receives: Dietary Supplement: High Olive Oil |
| DHA+EPA | Experimental | infants receiving capsule containing DHA and EPA. Receives: Dietary Supplement: DHA+EPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Analysis
Measured: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum
Metabolomics Study of PUFA
Measured: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum
Skin Prick Test to Common Allergens
Measured: 4 months postpartum, 12 months postpartum
Clinical Assessment of IgE-mediated Allergic Eczema
Measured: 4 months postpartum, 12 months postpartum
Secondary outcomes (4)
Fatty Acid Desaturase (FADS) Genotypes
Measured: Baseline
immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies
Measured: Baseline
Immunological Biomarkers
Measured: 4 months postpartum, 12 months postpartum
Medically-confirmed adverse events collected throughout the study period
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Investigators don't want to conduct this study as time is limited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Peace Maternity and Child Health Hospital, Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Zhiwei Liu, M.D., Principal investigator, International Peace Maternity and Child Health Hospital of China Welfare InstitutionHuiyong Yin, Ph.D., Principal investigator, Chinese Academy of SciencesBryan Liu, Ph.D., Study director, Mead Johnson & Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936194
- Sponsor's protocol ID
- 6018
- Status last verified
- Sep 2016
- First submitted
- 27 Aug 2013
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Polyunsaturated Fatty Acids on Allergic/Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01936194
- Acronym / sponsor ID
- 6018
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigators don't want to conduct this study as time is limited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- International Peace Maternity and Child Health Hospital, Chinese Academy of Sciences
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Sep 2013 (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.
This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Docosahexaenoic Acid (DHA) | Experimental | Dietary Supplement: DHAinfants receiving capsule containing DHA. |
| High Olive Oil | Other | Dietary Supplement: High Olive Oilinfants receiving capsule without DHA and EPA. |
| DHA+EPA | Experimental | Dietary Supplement: DHA+EPAinfants receiving capsule containing DHA and EPA. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Woman is pregnant between 16 and 20 weeks
- Mother delivers after 36 weeks
- Mother is willing to breast-feed for four months
- Mother has potential to deliver a child with increased risk of atopic dermatitis
- Signed Informed Consent
Key exclusion criteria (8 listed)
- Mother is smoking
- Disease with influence on breast feeding
- Complicated pregnancy
- Allergic to seafood
- Allergic to soy
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+EPA | Dietary supplement | DHA+EPA |
| High Olive Oil | Dietary supplement | High Olive Oil |
| DHA | Dietary supplement | Docosahexaenoic Acid (DHA) |
Primary outcome
Lipid Analysis
Time frame: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum
Metabolomics Study of PUFA
Time frame: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum
Skin Prick Test to Common Allergens
Time frame: 4 months postpartum, 12 months postpartum
Clinical Assessment of IgE-mediated Allergic Eczema
Time frame: 4 months postpartum, 12 months postpartum
4 secondary outcomes
Fatty Acid Desaturase (FADS) Genotypes
Time frame: Baseline
immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies
Time frame: Baseline
Immunological Biomarkers
Time frame: 4 months postpartum, 12 months postpartum
Medically-confirmed adverse events collected throughout the study period
Time frame: 12 months postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
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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.
Zhiwei Liu, M.D. principal investigator
International Peace Maternity and Child Health Hospital of China Welfare Institution
Huiyong Yin, Ph.D. principal investigator
Chinese Academy of Sciences
Bryan Liu, Ph.D. study director
Mead Johnson & Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA+EPA, High Olive Oil and DHA in people with Atopic Dermatitis, run by Mead Johnson Nutrition at 1 site in China.
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 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2016. 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 China. 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 was withdrawn before enrolling participants, so there are no results.
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?
Lipid Analysis (time frame: Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum). 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?
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 16 Sep 2016.