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| [ ...Back to search results ] | [ Print-friendly version ] |
| Dietary fish oil supplementation in pregnant women with diabetes |
| ISRCTN | ISRCTN68997518 |
| ClinicalTrials.gov identifier | |
| Public title | Dietary fish oil supplementation in pregnant women with diabetes |
| Scientific title | Dietary omega-3 and omega-6 fatty acids supplementation in pregnant women with diabetes: Randomised, double-blind, placebo-controlled trial |
| Acronym | FOSIP |
| Serial number at source | UKCRN ID 3772 |
| 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 one diabetes mellitus (T1DM; n = 80), type two diabetes mellitus (T2DM; n = 80), gestational (n = 80), healthy controls (n = 80) will be recruited from Newham University NHS Trust. As of 14/02/2012, the following changes have been made to the record. Public title was updated 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. Acronym was updated from Dietary fish oil supplementation in diabetic pregnancy DRN064 to FOSIP. Study design was updated from Single centre randomised interventional treatment trial to Randomised double-blind placebo-controlled trial. Target number of participants: Planned sample size was updated from 245; UK sample size: 245 to 320. Anticipated start date of trial was updated from 26/10/2007 to 01/06/2007. Anticipated end date of trial was updated from 01/05/2012 to 01/06/2012. |
| Lay summary |
Lay summary added as of 24/04/2012
Background and study aims Previous studies suggest that women with pre-existing diabetes (type 2 diabetes) or who develop diabetes during pregnancy (gestational diabetes) or have insufficient amount of certain nutrients when pregnant, their child has higher risk of becoming overweight and insulin resistant (which means your body do 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 either receive placebo (dummy) containing high oleic acid sunflower oil and the treatment group will receive capsules containing omega-3 and omega-6 fatty acids. 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 (Glen Road, Plaistow, London E13 8SL). When is 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 |
| Ethics approval |
Added as of 14/02/2012
East London & The City HA Local Research Ethics Committee 3 REC reference number: 06/Q0605/89 Previous ethics approval MREC approved on the 18th December 2006 (ref: 06/Q0605/89) |
| Study design | Randomised double-blind placebo-controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Diabetic pregnancy |
| Participants - 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 |
| Participants - exclusion criteria |
Current exclusion criteria as of 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. 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 1. Smokers 2. History of still birth 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 human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), kidney disease or congenital heart disease 9. Haematologic or autoimmune disease such as sickle cell disease 10. Other haemoglobinopathies 11. Lupus or antiphospholipids syndrome 12. Maternal or foetal conditions likely to require preterm delivery, such as pre-eclampsia, or intrauterine growth retardation |
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 01/06/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 320 (Amended as of 14/02/2012) |
| Interventions |
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 2.8mg 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 |
| Primary outcome measure(s) |
Current primary outcome measure(s) as of 14/02/2012
1. Maternal and foetal (cord) membrane lipid fatty acids levels at delivery Previous primary outcome measure(s) 1. Corrects the membrane lipid abnormality in diabetic mothers and their neonates |
| Secondary outcome measure(s) |
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. Up-regulates placental fatty acid-binding and -transporter proteins and their mRNAs |
| Sources of funding |
Current source of funding as of 14/02/2012
1. FP6 Marie Curie Actions-Transfer of Knowledge (Contract no. MTKD-CT-2005-029914) 2. The Foyle Foundation 3. The Mother and Child Foundation 4. The Letten Foundation 5. Vifor Pharma 6. Sir Halley Stewart Trust 7. Newham University Hospital NHS Trust 8. Diabetes Research Network (North East London Diabetes Local Research Network) Previous source of funding European Commission (Belgium) - The Sixth Framework Programme (FP6) |
| Trial website | http://www.londonmet.ac.uk/research-units/ibchn/research-projects/diabetes-in-pregnancy.cfm |
| Publications | |
| Contact name | Dr Yoeju Min |
| Address |
Faculty of Life Sciences,
London Metropolitan University 166-220 Holloway Road |
| City/town | London |
| Zip/Postcode | N7 8DB |
| Country | United Kingdom |
| y.min@londonmet.ac.uk | |
| Sponsor | Newham University Hospital NHS Trust (UK) |
| Address | Glen Road |
| City/town | Plaistow |
| Zip/Postcode | E13 8SL |
| Country | United Kingdom |
| Sponsor website: | http://www.newhamuniversityhospital.nhs.uk/main.cfm |
| Date applied | 30/07/2010 |
| Last edited | 24/04/2012 |
| Date ISRCTN assigned | 30/07/2010 |
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