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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047098
• Other study ID #: 200816261
• Status: Completed
• Phase: N/A
• First received: January 8, 2010
• Last updated: May 25, 2017
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Overload
• Iron-deficiency Anemia
• Oxidative Stress

Intervention

Dietary Supplement:
• Iron
Iron as iron sulfate
• Iron
Iron as iron sulfate
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress	Isoprostane and 8-OHdG	3 month
Primary	Iron status	Ferritin, transferrin saturation, hepcidin	3 month