Perelel Prenatal Supplements vs. Generic Prenatal Supplements and Health of Mother and Baby (SUPPORT)
Purpose
The goal of this clinical trial is to learn if using Perelel-brand prenatal supplements versus a generic prenatal supplement improves the health of the mother and fetus (unborn baby) during pregnancy. The main question it aims to answer is: • How does taking Perelel prenatal supplements versus generic prenatal supplements during pregnancy change the nutritional markers in blood samples? Participants will: - Take either Perelel or generic prenatal supplements daily throughout pregnancy - Visit UPMC Magee-Womens Hospital once every trimester of pregnancy for blood draws and answering questionnaires In an observational part of this study for different participants, researchers will use blood tests and questionnaires only once during the first trimester to compare pregnant women without food insecurity to those with food insecurity.
Condition
- Pregnancy
Eligibility
- Eligible Ages
- Over 14 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Pregnant with only one baby 2. Identify as having food insecurity 3. Receiving care at a Magee-Womens Hospital associated prenatal practice 4. Less than 12 weeks' of pregnancy
Exclusion Criteria
- Currently using prenatal supplement(s) 2. Unborn baby (fetus) identified as having a chromosomal or structural defect 3. Have a condition that prevents absorption of nutrients from food 4. History of medically treated thyroid disorder 5. Ongoing steroid use
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Perelel Prenatal Supplement Group |
|
|
|
Active Comparator Generic Prenatal Supplement Group |
|
|
|
No Intervention Observational Arm |
|
Recruiting Locations
Pittsburgh 5206379, Pennsylvania 6254927 15213
More Details
- Status
- Recruiting
- Sponsor
- University of Pittsburgh