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

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. To compare hemoglobin and iron status (ferritin, transferrin saturation, and hepcidin) before and after treatment among the three treatment groups described above.

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

Conditions
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Iron Overload, Oxidative Stress, Iron-deficiency Anemia

Intervention / Treatment
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* Dietary Supplement: Iron
* Dietary Supplement: Iron
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron with meals<br>Prenatal vitamin without iron plus capsule containing 27 mg of iron taken with meals | Dietary Supplement: Iron<br>* Iron as iron sulfate<br>|
| Experimental: Iron between meals<br>Prenatal vitamin without iron plus capsule containing 27 mg of iron taken between meals | Dietary Supplement: Iron<br>* Iron as iron sulfate<br>|
| Placebo Comparator: Placebo<br>Prenatal vitamin without iron plus capsule containing calcium carbonate (placebo) taken between meals | Dietary Supplement: Placebo<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress | Isoprostane and 8-OHdG | 3 month | 
| Iron status | Ferritin, transferrin saturation, hepcidin | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactation, Breastfeeding, Iron, Oxidative stress, Iron status and oxidative stress during lactation