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

University of California (UC) Davis

Status: Completed

Conditions: Vitamin A Deficiency

Treatments: Other: white maize and a corn oil capsule; Other: white maize and a vitamin A capsule; Other: orange maize and a corn oil capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT01922713

HP-8282

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

149 participants in 3 patient groups, including a placebo group

white maize

Placebo Comparator group

Description:

white maize and a corn oil capsule

Treatment:

Other: white maize and a corn oil capsule

orange maize

Experimental group

Description:

orange maize and a corn oil capsule

Treatment:

Other: orange maize and a corn oil capsule

vitamin A

Active Comparator group

Description:

white maize and a vitamin A capsule

Treatment:

Other: white maize and a vitamin A capsule