Plain English Summary
Background and study aims
Previous studies suggest that for women with pre-existing diabetes (type 2 diabetes) or who develop diabetes during pregnancy (gestational diabetes), or have insufficient amounts of certain nutrients when pregnant, their child has higher risk of becoming overweight and insulin resistant (which means your body does not control blood sugar efficiently). Moreover, children born to diabetic women are more vulnerable to develop diabetes and high blood pressure in adulthood. In our previous study, we have found that diabetic women and their newborn babies have lower levels of certain nutrients (omega-3 and omega-6 fatty acids) in the blood. These nutrients are found in various foods, for example you can find omega-3 in fish or seafood (mussel, crab, cockles, prawn, etc.) and omega-6 in eggs, offal, red meat or some fish. Evidence suggests that people with lower amounts of omega-3 and omega-6 fatty acids in their body may not be able to control blood sugar efficiently. Also, diabetics have lower amounts of these nutrients in their blood. The purpose of the study is to investigate if supplementing omega-3 and omega-6 fatty acids during pregnancy can improve women's health as well as their babies.
Who can participate?
Pregnant women with type 2 diabetes or gestational diabetes, without any other clinical condition.
What does the study involve?
Women will be randomly allocated to receive either capsules containing omega-3 and omega-6 fatty acids, or placebo (dummy) capsules containing sunflower oil.
What are the possible benefits and risks of participating?
The benefit of taking omega-3 and/or omega- 6 fatty acids in diabetic pregnancy is not yet known. However, the information we get from this study may help us to treat future patients with diabetes and their children better. Omega-3 fatty acids are nutrients widely present in fish and other marine food and do not present any risk.
Where is the study run from?
Recruitment of women, follow-up and clinical assessment will be conducted at the Newham University Hospital NHS Trust (UK).
When is the study starting and how long is it expected to run for?
The study started in June 2007 and expected to run for 5 years.
Who is funding the study?
FP6 Marie Curie Actions-Transfer of Knowledge (Contract no. MTKD-CT-2005-029914)
The Foyle Foundation
The Mother and Child Foundation
The Letten Foundation
Vifor Pharma
Sir Halley Stewart Trust
Newham University Hospital NHS Trust
Diabetes Research Network (North East London Diabetes Local Research Network)
Who is the main contact?
Dr Yoeju Min
y.min@londonmet.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Yoeju Min
ORCID ID
Contact details
Faculty of Life Sciences
London Metropolitan University
166-220 Holloway Road
London
N7 8DB
United Kingdom
-
y.min@londonmet.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UKCRN ID 3772
Study information
Scientific title
Dietary omega-3 and omega-6 fatty acids supplementation in pregnant women with diabetes: a randomised, double-blind, placebo-controlled trial
Acronym
FOSIP
Study hypothesis
Current hypothesis as of 14/02/2012:
Supplementation with DHA and AA during pregnancy will correct red cell membrane abnormality of the two fatty acids in diabetic women and neonates.
Previous hypothesis:
The study is a placebo-controlled, double-blind, randomised supplementation trial. A cohort of pregnant women with diabetes, type 1 diabetes mellitus (T1DM; n = 80), type 2 diabetes mellitus (T2DM; n = 80), gestational (n = 80), healthy controls (n = 80) will be recruited from Newham University NHS Trust.
On 14/02/2012 the following changes were made to the trial record:
1. The public title was changed from 'Dietary fish oil supplementation to improve maternal and foetal nutritional status in diabetic pregnancy' to 'Dietary Fish Oil Supplementation In Pregnant women with diabetes'.
2. The acronym was changed from 'Dietary fish oil supplementation in diabetic pregnancy DRN064' to 'FOSIP'.
3. The study design was changed from 'Single centre randomised interventional treatment trial' to 'Randomised double-blind placebo-controlled trial'.
4. The target number of participants was changed from 245 to 320.
5. The overall trial start date was changed from 26/10/2007 to 01/06/2007.
6. The overall trial end date was changed from 01/05/2012 to 01/06/2012.
On 21/06/2013 the sources of funding field was updated; the previous sources of funding were European Commission (Belgium) - The Sixth Framework Programme (FP6) and The Mother and Child Foundation.
Ethics approval
1. East London & The City HA Local Research Ethics Committee 3, REC ref: 06/Q0605/89
2. MREC,18/12/2006, ref: 06/Q0605/89
Study design
Randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetic pregnancy
Intervention
Current interventions as of 14/02/2012:
Subsequent to recruitment the diabetics (type 2 and gestational) and healthy non-diabetic controls will be randomly assigned to the treatment or the placebo group. The treatment groups will receive two gelatine capsules a day providing 600 mg DHA and 17 mg AA until delivery. The capsule also contains 2.8 mg of vitamin E per gram polyunsaturated fatty acids to prevent oxidation. The control (placebo) groups will receive one gelatine capsule per day containing an inert placebo (high oleic acid sunflower oil) and vitamin E per day until delivery.
Previous interventions:
Treatment (600 mg docosahexaenoic acid [DHA] and 200 mg arachidonic acid [AA]) until delivery. The treatment capsule also contains 10 µg of vitamin E per gram polyunsaturated fatty acids to prevent oxidation.
Follow-up length: 24 months
Study entry: registration and one or more randomisations
Intervention type
Supplement
Phase
Not Applicable
Drug names
Fish oil supplement
Primary outcome measure
Current primary outcome measure(s) as of 14/02/2012
1. Maternal and foetal (cord) membrane lipid fatty acid levels at delivery
Previous primary outcome measure(s)
1. Corrects the membrane lipid abnormality in diabetic mothers and their neonates
Secondary outcome measures
Current secondary outcome measure(s) as of 14/02/2012
1. Foetal body fat distribution
2. Placental lipid fatty acids composition and expression of placental fatty acid binding and transporter proteins
Previous secondary outcome measure(s)
1. Enhances insulin sensitivity in women with gestational diabetes
2. Upregulates placental fatty acid-binding and -transporter proteins and their mRNAs
Overall trial start date
01/06/2007
Overall trial end date
01/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 14/02/2012:
1. Pregnant women aged 17-45 years old without any medical condition
2. Pregnant women aged 17-45 years old with diabetes (type 2 diabetes or gestational diabetes)
Previous inclusion criteria:
1. Pregnant women with or without diabetes (type 1, type 2, gestational diabetes)
2. Eligible age: 17 - 40 years
3. Control subjects without diabetes
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
320
Participant exclusion criteria
Current exclusion criteria as of 21/06/2013:
1. Pregnancy with more than one foetus
2. Known major foetal anomaly
3. Current or planned corticosteroid therapy
4. Asthma requiring medication
5. Current or planned beta-adrenergic therapy
6. Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
7. Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
8. Previous or planned tocolytic therapy to induce labour or increase contraction strength
Previous exclusion criteria until 21/06/2013:
1. Smokers
2. History of stillbirth or foetal death
3. Pregnancy with more than one foetus
4. Known major foetal anomaly
5. Current or planned corticosteroid therapy
6. Asthma requiring medication
7. Current or planned beta-adrenergic therapy
8. Chronic hypertension requiring medication within 6 months of or during pregnancy
9. Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
10. Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
11.Maternal or foetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labour, or intrauterine growth retardation
12. Previous or planned tocolytic therapy to induce labour or increase contraction strength
Previous exclusion criteria until 14/02/2012:
1. Smokers
2. History of stillbirth or foetal death
3. Pregnancy with more than one foetus
4. Known major foetal anomaly
5. Asthma requiring medication
6. Current or planned beta-adrenergic therapy
7. Chronic hypertension requiring medication within 6 months of, or during, pregnancy
8. Chronic medical conditions such as HIV/AIDS, kidney disease or congenital heart disease
9. Haematologic or autoimmune disease such as sickle cell disease
10. Other haemoglobinopathies
11. Lupus or antiphospholipid syndrome
12. Maternal or foetal conditions likely to require preterm delivery, such as pre-eclampsia, or intrauterine growth retardation
Recruitment start date
01/06/2007
Recruitment end date
01/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
London Metropolitan University
London
N7 8DB
United Kingdom
Sponsor information
Organisation
Newham University Hospital NHS Trust (UK)
Sponsor details
Glen Road
Plaistow
E13 8SL
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
FP6 Marie Curie Actions-Transfer of Knowledge (Contract no. MTKD-CT-2005-029914)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foyle Foundation
Alternative name(s)
FF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Funder name
Letten Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Vifor Pharma
Alternative name(s)
Vifor Pharma Ltd., Vifor Pharma Management Ltd., Vifor Pharma Management AG, Vifor Pharma Management SA
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Switzerland
Funder name
Sir Halley Stewart Trust
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Newham University Hospital NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Diabetes Research Network (North East London Diabetes Local Research Network)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in http://www.ncbi.nlm.nih.gov/pubmed/24925713
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26091965