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

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ClinicalTrials.gov Identifier: NCT01047098
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Iron Overload Oxidative Stress Iron-deficiency Anemia Dietary Supplement: Iron Dietary Supplement: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Oxidative stress [ Time Frame: 3 month ]
    Isoprostane and 8-OHdG

  2. Iron status [ Time Frame: 3 month ]
    Ferritin, transferrin saturation, hepcidin



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01047098     History of Changes
Other Study ID Numbers: 200816261
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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
Iron Overload
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamins
Iron
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements