NCT01420406

Brief Summary

The study will assess the relative bioavailability and bioefficacy of cryptoxanthin (CX) and beta-carotene (BC) from food sources for increasing breast milk carotenoid and retinol concentrations in lactating Bangladeshi women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

August 17, 2011

Last Update Submit

September 11, 2012

Conditions

Vitamin A Deficiency

Keywords

lactationcryptoxanthinbeta-carotenevitamin A

Outcome Measures

Primary Outcomes (1)

  • Change in carotenoids in serum and breast milk

    We will measure serum and breast milk beta-carotene, beta-cryptoxanthin, other carotenoids, and vitamins A and E.

    1 and 3 weeks

Secondary Outcomes (1)

  • Change in Dark adaptation

    1 and 3 weeks

Study Arms (4)

0 mg retinol

PLACEBO COMPARATOR

0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule

Other: 0 mg retinol activity equivalents

12 mg BC

EXPERIMENTAL

12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule.

Other: 12 mg of BC

6 mg of CX

EXPERIMENTAL

6 mg of CX as tangerines and a corn oil capsule

Other: 6 mg of CX

1.0 mg RAE

EXPERIMENTAL

1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes

Other: 1.0 mg RAE

Interventions

0 mg retinol activity equivalentsOTHER

0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule

0 mg retinol
12 mg of BCOTHER

12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule

12 mg BC
6 mg of CXOTHER

6 mg of CX as tangerines and a corn oil capsule

6 mg of CX
1.0 mg RAEOTHER

1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes

1.0 mg RAE

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy women in Dhaka, Bangladesh
  • Lactating women in their 2nd or 3rd month of lactation who are planning to breast-feed at least 6 months
  • Breast-feeding only one infant
  • Age range 18 to 45 years
  • Not pregnant
  • Serum retinol concentrations \>0.70 umol/L and \<1.10 umol/L
  • Normal concentrations of CRP (\<10 mg/L)
  • At least one arm vein deemed adequate for blood collection, as evaluated by a screening nurse.
  • Willing to consume the test foods daily 6 d/wk for one month

You may not qualify if:

  • Severe anemia (Hb \<9 mg/dL)
  • Current pregnancy
  • Must not have known allergy to citrus fruit (tangerines or mandarin oranges) or sweet potatoes
  • Must have no obvious psychological or sociological problems-such as alcoholism, drug abuse, or severe and acute mental illness that would influence their ability to sign an inform consent agreement or to participate in study duties and activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

Location

Related Publications (1)

  • Turner T, Burri BJ, Jamil KM, Jamil M. The effects of daily consumption of beta-cryptoxanthin-rich tangerines and beta-carotene-rich sweet potatoes on vitamin A and carotenoid concentrations in plasma and breast milk of Bangladeshi women with low vitamin A status in a randomized controlled trial. Am J Clin Nutr. 2013 Nov;98(5):1200-8. doi: 10.3945/ajcn.113.058180. Epub 2013 Sep 4.

    PMID: 24004891DERIVED

MeSH Terms

Conditions

Vitamin A DeficiencyBreast Feeding

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Study Officials

  • Betty J Burri, PhD

    WHNRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 19, 2011

Study Start

June 1, 2010

Primary Completion

May 1, 2011

Study Completion

June 1, 2012

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

BA(1)