Clinical Trials Directory

Trials / Completed

CompletedNCT01047098

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
114 (actual)
Sponsor
University of California, Davis · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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: 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTIronIron as iron sulfate
DIETARY_SUPPLEMENTIronIron as iron sulfate
DIETARY_SUPPLEMENTPlaceboPlacebo capsule

Timeline

Start date
2008-10-01
Primary completion
2010-04-01
Completion
2010-04-01
First posted
2010-01-12
Last updated
2017-05-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01047098. Inclusion in this directory is not an endorsement.

Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation (NCT01047098) · Clinical Trials Directory