NCT01047098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

January 8, 2010

Last Update Submit

May 25, 2017

Conditions

Iron OverloadOxidative StressIron-deficiency Anemia

Keywords

LactationBreastfeedingIronOxidative stressIron status and oxidative stress during lactation

Outcome Measures

Primary Outcomes (2)

  • Oxidative stress

    Isoprostane and 8-OHdG

    3 month

  • Iron status

    Ferritin, transferrin saturation, hepcidin

    3 month

Study Arms (3)

Iron with meals

EXPERIMENTAL

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

Dietary Supplement: Iron

Iron between meals

EXPERIMENTAL

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

Dietary Supplement: Iron

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

IronDIETARY_SUPPLEMENT

Iron as iron sulfate

Iron with meals
PlaceboDIETARY_SUPPLEMENT

Placebo capsule

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women less than 4 weeks postpartum
  • years of age or older
  • Took prenatal vitamins for at least 3 months during pregnancy
  • Successfully initiated breastfeeding

You may not qualify if:

  • Anemic (Hgb \< 110 g/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Iron OverloadAnemia, Iron-DeficiencyBreast Feeding

Interventions

Iron

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Kathryn G Dewey, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 12, 2010

Study Start

October 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)