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

Not Applicable
Completed
Conditions
Vitamin A Deficiency
Registration Number
NCT01922713
Lead Sponsor
University of California, Davis
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
149
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Breast milk retinol concentrationAfter 3 weeks of intervention

Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)

Secondary Outcome Measures
NameTimeMethod
Breastmilk beta-carotene concentrationAfter 3 wk of intervention

Breastmilk beta-carotene concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)

Trial Locations

Locations (1)

Center for Human Nutrition

🇿🇲

Mkushi, Mkushi District, Zambia

Center for Human Nutrition
🇿🇲Mkushi, Mkushi District, Zambia

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