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CompletedNCT01047098Updated May 30, 2017

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

An interventional study of Iron and Iron in Iron Overload, Oxidative Stress and Iron-deficiency Anemia, sponsored by University of California, Davis. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by University of California, Davis · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Iron Overload
  • Oxidative Stress
  • Iron-deficiency Anemia

Keywords

  • Lactation
  • Breastfeeding
  • Iron
  • Oxidative stress
  • Iron status and oxidative stress during lactation
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 114 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Anemic (Hgb \< 110 g/L)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    Iron with meals

    Prenatal vitamin without iron plus capsule containing 27 mg of iron taken with meals

    Dietary Supplement: Iron

  • Experimental
    Iron between meals

    Prenatal vitamin without iron plus capsule containing 27 mg of iron taken between meals

    Dietary Supplement: Iron

  • Placebo comparator
    Placebo

    Prenatal vitamin without iron plus capsule containing calcium carbonate (placebo) taken between meals

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementIron

    Iron as iron sulfate

  • Dietary supplementIron

    Iron as iron sulfate

  • Dietary supplementPlacebo

    Placebo capsule

06

What researchers measure

Primary outcomes

  1. Oxidative stress

    Isoprostane and 8-OHdG

    Time frame: 3 month

  2. Iron status

    Ferritin, transferrin saturation, hepcidin

    Time frame: 3 month

07

Study locations

1 site
  • UC Davis Medical Center
    Sacramento, California 95817, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01047098
Lead sponsor
University of California, Davis
Responsible party
Sponsor
First posted
Jan 12, 2010
Start date
Oct 2008
Primary completion
Apr 2010
Completion
Apr 2010
Last update
May 30, 2017

Study contacts

Kathryn G Dewey, PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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