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

University of California (UC) Davis

Status: Completed

Conditions: Iron Overload; Oxidative Stress; Iron-deficiency Anemia

Treatments: Dietary Supplement: Iron; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01047098

200816261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 3 patient groups, including a placebo group

Iron with meals

Experimental group

Description:

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

Treatment:

Dietary Supplement: Iron

Dietary Supplement: Iron

Iron between meals

Experimental group

Description:

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

Treatment:

Dietary Supplement: Iron

Dietary Supplement: Iron

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo