Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kathryn Dewey, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01047098
First received: January 8, 2010
Last updated: December 16, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Iron Overload
Oxidative Stress
Iron-deficiency Anemia
Dietary Supplement: Iron
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Oxidative stress [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Isoprostane and 8-OHdG

  • Iron status [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Ferritin, transferrin saturation, hepcidin


Enrollment: 114
Study Start Date: October 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron with meals
Prenatal vitamin without iron plus capsule containing 27 mg of iron taken with meals
Dietary Supplement: Iron
Iron as iron sulfate
Experimental: Iron between meals
Prenatal vitamin without iron plus capsule containing 27 mg of iron taken between meals
Dietary Supplement: Iron
Iron as iron sulfate
Placebo Comparator: Placebo
Prenatal vitamin without iron plus capsule containing calcium carbonate (placebo) taken between meals
Dietary Supplement: Placebo
Placebo capsule

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:

  1. 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.
  2. To compare hemoglobin and iron status (ferritin, transferrin saturation, and hepcidin) before and after treatment among the three treatment groups described above.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047098

Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Kathryn G Dewey, PhD Professor
  More Information

No publications provided

Responsible Party: Kathryn Dewey, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01047098     History of Changes
Other Study ID Numbers: 200816261
Study First Received: January 8, 2010
Last Updated: December 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Lactation
Breastfeeding
Iron
Oxidative stress
Iron status and oxidative stress during lactation

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on March 26, 2015