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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01936194
Other study ID # 6018
Secondary ID
Status Withdrawn
Phase N/A
First received August 27, 2013
Last updated September 15, 2016
Start date September 2013
Est. completion date November 2014

Study information

Verified date September 2016
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
DHA+EPA

High Olive Oil

DHA


Locations

Country Name City State
China International Peace Maternity and Child Health Hospital of China welfare Institute Shanghai Shanghai

Sponsors (3)

Lead Sponsor Collaborator
Mead Johnson Nutrition Chinese Academy of Sciences, International Peace Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lipid Analysis Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum No
Primary Metabolomics Study of PUFA Baseline, Delivery, Within one week after delivery, 6 weeks postpartum, 4 months postpartum, 12 months postpartum No
Primary Skin Prick Test to Common Allergens 4 months postpartum, 12 months postpartum No
Primary Clinical Assessment of IgE-mediated Allergic Eczema 4 months postpartum, 12 months postpartum No
Secondary Fatty Acid Desaturase (FADS) Genotypes Baseline No
Secondary immunoglobulin E immunoglobulin E Immunoglobulin E (IgE) Antibodies Baseline No
Secondary Immunological Biomarkers 4 months postpartum, 12 months postpartum No
Secondary Medically-confirmed adverse events collected throughout the study period 12 months postpartum No
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