Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT02140879 |
| Other study ID # |
PBRC 11031 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2014 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
September 2022 |
| Source |
Pennington Biomedical Research Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research study will examine how diet during pregnancy can benefit pregnancy and
pregnancy outcome, such as your baby's weight. More specifically, the investigators will
study the effects of two different food oils/fats that are commonly consumed to determine if
one is more effective in limiting maternal inflammation during pregnancy. You are being asked
to take part in this study because it will help us update and make the best dietary
recommendations for pregnant women and women of child bearing ages.
Description:
Pregnant women will be asked to consume dietary supplements (2 capsules, from the Pennington
Biomedical Pharmacy) each day during pregnancy. They will begin taking the capsules around 17
weeks of pregnancy and take them each day until their babies are born. Women will be
randomized to one of two groups. Randomization means they will be put into a group by chance,
similar to flipping a coin. One group, the placebo group of the study, will take capsules
containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement
group, will take capsules containing oil '2' which is an algal oil. Both oils are found in
our diets. Neither the subject nor the study staff will know which group women are in.
Women will also keep a diary of how many capsules they take. At around 17, 22, 24, 26, 30,
32, and 36 weeks of pregnancy, women will go to Woman's Hospital to get new capsules and
return any remaining capsules and their capsule diary. If they are not able to go to Woman's
Hospital at weeks 22, 26, or 32 a researcher will arrange to meet them at an agreed upon
prearranged place, such as a pharmacy, a library, or Pennington Biomedical, for example. At
the same visits to Woman's Hospital at weeks 17, 24, 30, and 36 weeks of pregnancy women will
also have their blood drawn (approximately one tablespoon).
At 17, 22, 24, 26, 30, 32 and 36 weeks of pregnancy we will also ask women about the foods
they are eating. We will do this by a prearranged phone call; women will not need to meet us
in person for this.
Researchers will contact subjects weekly by phone to inquire about compliance with
consumption of capsules. Contact will only take place during weeks in which a visit or phone
call regarding diet is not required.
At 17, 24, 30, and 36 weeks of pregnancy small blood samples will be collected from their arm
(approximately one tablespoon at each collection) for laboratory analyses. At the birth of
their baby a sample of blood will be collected from the umbilical cord after their baby is
delivered. All blood samples will be stored at Pennington Biomedical. Blood samples will be
analyzed by the researchers who are involved in the study. Some analyses will take place at
Pennington Biomedical and Louisiana State University (LSU). Deidentified (without subject
names) samples will be sent to study researchers at Northeastern University in Boston, LSU
Health Sciences Center in New Orleans, and DSM Nutritional Products in Columbia, Maryland for
some of the analyses. At the end of the study remaining blood samples will be discarded
unless women consent for their blood to be used for future research. Should women decide to
withdraw from the study, any samples collected thus far will be included in the study since
they will be deidentified and the investigators will not know which samples belong to each
person. We will also collect information about the baby's birth weight, length, and health
from the baby's hospital chart.
When the baby is 2 weeks, 6 months, and 12 months of age we will measure the baby's body fat
and lean tissue. To do this measurement the baby will lie or sit in an enclosed chamber where
the mother can see her baby during the measurements. There are no attachments made to the
baby. At these times we will also determine the baby's body fat by measuring the thickness of
the baby's skinfold; this is done by gently lifting a double fold of skin on the baby's hip,
upper arm (triceps), and back of the thigh and measuring the thickness of that fold with a
handheld instrument with two hinged arms that fit over the skinfold. There is no discomfort
associated with this procedure. The measurements will be made at Woman's Hospital. During
these visits we will also ask questions about how the mother is feeding her baby. Between
these visits (when the baby is 2, 4, 8, and 10 months old) we will phone to ask about how the
baby is being fed and to inquire about the mother's and baby's well-being.
