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

Not Applicable

Completed

• Conditions: Vitamin A Deficiency
• Interventions: Other: white maize and a vitamin A capsule; Other: white maize and a corn oil capsule; Other: orange maize and a corn oil capsule

• 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.

Study Timeline

• Study First Submitted: 2013-08-12
• Study First Submitted QC: 2013-08-13
• Study First Posted: 2013-08-14
• Study Start: 2013-10
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

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

Arm && Interventions

Group	Intervention	Description
vitamin A	white maize and a vitamin A capsule	white maize and a vitamin A capsule
white maize	white maize and a corn oil capsule	white maize and a corn oil capsule
orange maize	orange maize and a corn oil capsule	orange maize and a corn oil capsule

Primary Outcome Measures

Name	Time	Method
Breast milk retinol concentration	After 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

Name	Time	Method
Breastmilk beta-carotene concentration	After 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