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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
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
January 8, 2010
Last Updated
May 25, 2017
Sponsor
University of California, Davis
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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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