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OpenTrials
Completed

NCT Number: NCT01922713

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

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.

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Key information

Conditions

Vitamin A Deficiency Avitaminosis Callosities Deficiency Diseases Keratosis Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Human Nutrition

Mkushi, Mkushi District, Zambia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

white maize and a corn oil capsule

Other

~ 0 ug RAE/d

orange maize and a corn oil capsule

Other

~600 ug RAE/d

Other names: beta-carotene biofortified maize

white maize and a vitamin A capsule

Other

600 ug RAE/d

Other names: retinyl palmitate capsule

Primary outcomes

  1. Breast milk retinol concentration

    Time frame: 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 outcomes

  1. Breastmilk beta-carotene concentration

    Time frame: 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 outcomes

  1. Plasma retinol concentration

    Time frame: After 3 wk of intervention

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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Johns Hopkins University
  • Tropical Diseases Research Centre, Zambia

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Aug 14, 2013
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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