Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women

Study Overview
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Brief Summary
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The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.

Detailed Description
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Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received  600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.

Official Title
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Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women

Conditions
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Vitamin A Deficiency

Intervention / Treatment
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* Other: white maize and a corn oil capsule
* Other: orange maize and a corn oil capsule
* Other: white maize and a vitamin A capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy lactating women 18-35 years of age who are breastfeeding a single infant, 4-12 mo of age. Exclusion Criteria: Pregnancy, Chronic disease, Hb concentration <90 g/L, Signs or symptoms of vitamin A deficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: white maize<br>white maize and a corn oil capsule | Other: white maize and a corn oil capsule<br>*   0 ug RAE/d<br>|
| Experimental: orange maize<br>orange maize and a corn oil capsule | Other: orange maize and a corn oil capsule<br>*  600 ug RAE/d<br>* Other names: beta-carotene biofortified maize;|
| Active Comparator: vitamin A<br>white maize and a vitamin A capsule | Other: white maize and a vitamin A capsule<br>* 600 ug RAE/d<br>* Other names: retinyl palmitate capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk retinol concentration | Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk) | After 3 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastmilk beta-carotene concentration | Breastmilk beta-carotene concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk) | After 3 wk of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maize, biofortification, vitamin A, beta-carotene, breastmilk, Zambia