Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
Primary Purpose
Iron Overload, Oxidative Stress, Iron-deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iron
Iron
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Iron Overload focused on measuring Lactation, Breastfeeding, Iron, Oxidative stress, Iron status and oxidative stress during lactation
Eligibility Criteria
Inclusion Criteria:
- Women less than 4 weeks postpartum
- 18 years of age or older
- Took prenatal vitamins for at least 3 months during pregnancy
- Successfully initiated breastfeeding
Exclusion Criteria:
- Anemic (Hgb < 110 g/L)
Sites / Locations
- UC Davis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Iron with meals
Iron between meals
Placebo
Arm Description
Prenatal vitamin without iron plus capsule containing 27 mg of iron taken with meals
Prenatal vitamin without iron plus capsule containing 27 mg of iron taken between meals
Prenatal vitamin without iron plus capsule containing calcium carbonate (placebo) taken between meals
Outcomes
Primary Outcome Measures
Oxidative stress
Isoprostane and 8-OHdG
Iron status
Ferritin, transferrin saturation, hepcidin
Secondary Outcome Measures
Full Information
NCT ID
NCT01047098
First Posted
January 8, 2010
Last Updated
May 25, 2017
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT01047098
Brief Title
Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
Official Title
Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Most breastfeeding women are told by their health care provider to continue taking prenatal vitamins after they give birth. A woman's requirement for iron while breastfeeding is low, yet prenatal vitamins contain a large amount of iron. The purpose of this study is to see if breastfeeding women are getting too much iron when taking prenatal vitamins.
Detailed Description
Even though iron requirements are much lower for lactating women than for pregnant or non-pregnant, non-lactating women, and iron stores during lactation are often high due to release of iron from the additional maternal erythrocytes produced during pregnancy, iron supplements are often taken by lactating women in the U.S. Many studies have shown that higher iron status is associated with higher risk of certain chronic diseases (e.g. cancer and cardiovascular diseases). The overall goal of this proposed study is to understand the potential for oxidative stress due to iron supplementation, and possible mechanisms for these effects, and to identify safe and efficacious ways to ensure adequate iron status during lactation. The specific aims are:
To compare markers of lipid oxidation (urinary isoprostane) and DNA damage (urinary 8-OHdG (urinary 8-hydroxy-2'-deoxyguanosine)) among 3 treatment groups: (iron given between meals (27 mg daily, in a multivitamin-mineral supplement), iron given with meals (27 mg daily, in a multivitamin-mineral supplement) and multivitamin-mineral supplement with no iron, given between meals) at the beginning and end of 3 months of treatment in 114 lactating women.
To compare hemoglobin and iron status (ferritin, transferrin saturation, and hepcidin) before and after treatment among the three treatment groups described above.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Overload, Oxidative Stress, Iron-deficiency Anemia
Keywords
Lactation, Breastfeeding, Iron, Oxidative stress, Iron status and oxidative stress during lactation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron with meals
Arm Type
Experimental
Arm Description
Prenatal vitamin without iron plus capsule containing 27 mg of iron taken with meals
Arm Title
Iron between meals
Arm Type
Experimental
Arm Description
Prenatal vitamin without iron plus capsule containing 27 mg of iron taken between meals
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Prenatal vitamin without iron plus capsule containing calcium carbonate (placebo) taken between meals
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron
Intervention Description
Iron as iron sulfate
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron
Intervention Description
Iron as iron sulfate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule
Primary Outcome Measure Information:
Title
Oxidative stress
Description
Isoprostane and 8-OHdG
Time Frame
3 month
Title
Iron status
Description
Ferritin, transferrin saturation, hepcidin
Time Frame
3 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women less than 4 weeks postpartum
18 years of age or older
Took prenatal vitamins for at least 3 months during pregnancy
Successfully initiated breastfeeding
Exclusion Criteria:
Anemic (Hgb < 110 g/L)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn G Dewey, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation
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