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

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT01047098
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 3
• Duration (Months): 18
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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: Iron; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• 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: Oct 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Oxidative stress [3 month]

   Isoprostane and 8-OHdG

2. Iron status [3 month]

   Ferritin, transferrin saturation, hepcidin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• Anemic (Hgb < 110 g/L)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Davis Medical Center	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Kathryn G Dewey, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT01047098
• Other Study ID Numbers: 200816261
• First Posted: Jan 12, 2010
• Last Update Posted: May 30, 2017
• Last Verified: May 1, 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; Iron

Study Results

No Results Posted as of May 30, 2017