NCT00453648

Brief Summary

The primary purpose of this study is to determine whether daily consumption of orange-fleshed sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age. Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in Bangladeshi women of reproductive age.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

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

March 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3.8 years

First QC Date

March 27, 2007

Last Update Submit

May 24, 2017

Conditions

Vitamin A Deficiency

Keywords

stable isotopesvitamin Abeta-caroteneorange-fleshed sweet potatoesironzincabsorptionbioavailabilityvitamin A equivalencyBangladeshwomen

Outcome Measures

Primary Outcomes (1)

  • Total body vitamin A pool size

    3 years

Secondary Outcomes (1)

  • Iron absorption

    3 years

Study Arms (4)

White-fleshed Sweet Potato

PLACEBO COMPARATOR

0 ug retinol activity equivalents (RAE)/d as boiled white-fleshed sweet potatoes (WFSP) and a corn oil capsule, 6d/wk for 10 wk

Other: White-fleshed sweet potatoes

Orange-fleshed Sweet Potato (boiled)

EXPERIMENTAL

600 ug RAE/d as boiled orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk

Other: Orange-fleshed sweet potatoes (boiled)

Orange-fleshed Sweet Potato (fried)

EXPERIMENTAL

600 ug RAE/d as fried orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk

Other: Orange-fleshed sweet potatoes (fried)

White-fleshed Sweet Potato and retinyl palmitate capsule

ACTIVE COMPARATOR

0 ug RAE/d as white-fleshed sweet potato and 600 ug retinol/d as retinyl palmitate, 6d/wk for 10 wk

Other: WFSP and capsule of retinyl palmitate

Interventions

White-fleshed sweet potatoesOTHER
White-fleshed Sweet Potato
Orange-fleshed sweet potatoes (boiled)OTHER
Orange-fleshed Sweet Potato (boiled)
Orange-fleshed sweet potatoes (fried)OTHER
Orange-fleshed Sweet Potato (fried)
WFSP and capsule of retinyl palmitateOTHER
White-fleshed Sweet Potato and retinyl palmitate capsule

Eligibility Criteria

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

You may qualify if:

  • Serum retinol concentration \< 1.12 umol/L
  • Serum C-reactive protein concentration \< 10 mg/L

You may not qualify if:

  • Pregnant
  • Lactating
  • Diarrhea within past week
  • Severe anemia (\< 9g Hb/dL)
  • Symptoms of nightblindness
  • Clinical symptoms of xerophthalmia
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jamil KM, Brown KH, Jamil M, Peerson JM, Keenan AH, Newman JW, Haskell MJ. Daily consumption of orange-fleshed sweet potato for 60 days increased plasma beta-carotene concentration but did not increase total body vitamin A pool size in Bangladeshi women. J Nutr. 2012 Oct;142(10):1896-902. doi: 10.3945/jn.112.164830. Epub 2012 Aug 29.

    PMID: 22933750DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Marjorie J Haskell, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Kenneth H Brown, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Kazi Jamil, MBBS, PhD

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

March 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 30, 2017

Record last verified: 2017-05