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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01922713

Enrollment

149

Registered

2013-08-14

Start date

2013-10-31

Completion date

2014-12-31

Last updated

2015-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin A Deficiency

Keywords

biofortification, vitamin A, maize, beta-carotene, breastmilk, Zambia

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.

Interventions

OTHERwhite maize and a corn oil capsule

\ 0 ug RAE/d

OTHERwhite maize and a vitamin A capsule

600 ug RAE/d

OTHERorange maize and a corn oil capsule

\ 600 ug RAE/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
Plasma retinol concentration	After 3 wk of intervention	Plasma retinol concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026