NCT01922713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

August 12, 2013

Last Update Submit

January 22, 2015

Conditions

Vitamin A Deficiency

Keywords

biofortificationvitamin Amaizebeta-carotenebreastmilkZambia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Breastmilk beta-carotene concentration

    After 3 wk of intervention

Other Outcomes (1)

  • Plasma retinol concentration

    After 3 wk of intervention

Study Arms (3)

white maize

PLACEBO COMPARATOR

white maize and a corn oil capsule

Other: white maize and a corn oil capsule

orange maize

EXPERIMENTAL

orange maize and a corn oil capsule

Other: orange maize and a corn oil capsule

vitamin A

ACTIVE COMPARATOR

white maize and a vitamin A capsule

Other: white maize and a vitamin A capsule

Interventions

white maize and a corn oil capsuleOTHER

\~ 0 ug RAE/d

white maize
orange maize and a corn oil capsuleOTHER

\~600 ug RAE/d

Also known as: beta-carotene biofortified maize
orange maize
white maize and a vitamin A capsuleOTHER

600 ug RAE/d

Also known as: retinyl palmitate capsule
vitamin A

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy lactating women 18-35 years of age
  • who are breastfeeding a single infant, 4-12 mo of age.

You may not qualify if:

  • Pregnancy,
  • Chronic disease,
  • Hb concentration \<90 g/L,
  • Signs or symptoms of vitamin A deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Human Nutrition

Mkushi, Mkushi District, Zambia

Location

Related Publications (1)

  • Palmer AC, Chileshe J, Hall AG, Barffour MA, Molobeka N, West KP Jr, Haskell MJ. Short-Term Daily Consumption of Provitamin A Carotenoid-Biofortified Maize Has Limited Impact on Breast Milk Retinol Concentrations in Zambian Women Enrolled in a Randomized Controlled Feeding Trial. J Nutr. 2016 Sep;146(9):1783-92. doi: 10.3945/jn.116.233700. Epub 2016 Jul 27.

    PMID: 27466608DERIVED

MeSH Terms

Conditions

Vitamin A DeficiencyCallosities

Interventions

Vitamin Aretinol palmitate

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Marjorie Haskell, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

ZA(1)