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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01047098
First received: January 8, 2010
Last updated: January 11, 2010
Last verified: January 2010
History of Changes
  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 Status
Oxidative Stress
 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Oxidative stress [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Iron status [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxylipid profile [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 108
Study Start Date: October 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron with meals
30 mg of iron taken with meals
 Dietary Supplement: Iron
Iron as iron sulfate
Experimental: Iron between meals
30 mg of iron taken between meals
 Dietary Supplement: Iron
Iron as iron sulfate
Placebo Comparator: Placebo 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 (30 mg daily, in a multivitamin-mineral supplement), iron given with meals (30 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 105 lactating women.
  2. To compare hemoglobin and iron status (ferritin and hepcidin) before and after treatment among the three treatment groups described above.
  3. To explore the oxylipids profile at the end of 3 months of treatment in a subsample of 24 women in the 3 treatment groups above, selected based on their isoprostane or 8-OHdG response.
  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
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, University of California, Davis
ClinicalTrials.gov Identifier: NCT01047098     History of Changes
Other Study ID Numbers: 200816261
Study First Received: January 8, 2010
Last Updated: January 11, 2010
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:
Vitamins
Iron
Micronutrients
Growth Substances
 Physiological Effects of Drugs
Pharmacologic Actions
Trace Elements

ClinicalTrials.gov processed this record on June 18, 2013