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

Vitamin A Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922713
• Other study ID #: HP-8282
• Status: Completed
• Phase: N/A
• First received: August 12, 2013
• Last updated: January 22, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Other:
• white maize and a corn oil capsule
~ 0 ug RAE/d
• orange maize and a corn oil capsule
~600 ug RAE/d
• white maize and a vitamin A capsule
600 ug RAE/d

Locations

Country	Name	City	State
Zambia	Center for Human Nutrition	Mkushi	Mkushi District

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Johns Hopkins University, Tropical Diseases Research Centre, Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma retinol concentration	Plasma retinol concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)	After 3 wk of intervention	No
Primary	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	No
Secondary	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	No