Source: isrctn

A trial to investigate the role of the food supplement inositol in the general health of those at risk of developing gestational diabetes mellitus Background and study aims Gestational diabetes mellitus is a form of diabetes that can occur in pregnancy. This can affect both mother and baby during the course of the pregnancy and delivery. Inositol is a food supplement which has been shown in small studies to have health benefits including reducing the incidence of gestational diabetes in those at risk of getting it. The aim of our study is to find out the possible health benefits of Inositol for women at risk. This includes finding out if they have a decreased incidence of gestational diabetes, if they have fewer complications during delivery, if their baby's weight is affected and if their baby's first few days of life is affected. Who can participate? Women who are 10-14 weeks pregnant and who are at risk of developing gestational diabetes due to a family history of diabetes, can participate in the study. What does the study involve? Participants will be randomly allocated to one of two groups: the intervention group or the placebo (dummy) group. The intervention group will take one tablet every day containing Inositol combined with folic acid and the placebo group will take folic acid alone. They will then follow standard care and be tested as routine for gestational diabetes at 26 weeks. If they have diabetes they will attend the diabetes clinic and if not they will follow standard care. Their pregnancy will be followed until delivery. The type of delivery they have, the weight or their baby and any complications for themselves or their baby will be recorded. What are the possible benefits and risks of participating? The benefit of participating in this study is that it may have health benefits for them. There are no expected risks in participating. Studies have not shown any side effects of Inositol at the doses we are using. Where is the study run from? The study will be run in the Coombe Women and Infant's University Hospital, Ireland. When is the study starting and how long is it expected to run for? The study is expected to run from November 2013 to June 2015. Who is funding the study? The Coombe Women and Infants University Hospital, Ireland. Who is the main contact? Dr Maria Farren

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Closed trial