Impact of Consumption of Orange-fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age

This study has been completed.
Sponsor:
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00453648
First received: March 27, 2007
Last updated: January 19, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Vitamin A Deficiency
Behavioral: Consumption of orange-fleshed sweet potatoes

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Daily Consumption of Sweet Potatoes for Increasing Total Body Vitamin A Pool Size, and the Effect of Consumption of Sweet Potatoes on Iron and Zinc Absorption in Bangladeshi Women of Reproductive Age

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Total body vitamin A pool size [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Iron absorption [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: March 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Consumption of orange-fleshed sweet potatoes
    Two servings of orange-fleshed sweet potatoes are delivered to women daily for 60 days
    Other Name: sweet potatoes
Detailed Description:

Biofortification of plant source foods is a promising strategy for increasing dietary vitamin A intake and vitamin A status in populations at risk of deficiency. The primary purposes of this study are:

  1. to assess the efficacy of daily consumption of boiled or fried orange-fleshed sweet potatoes (OFSP) for increasing the vitamin A status of non-pregnant, non-lactating Bangladeshi women, and
  2. to estimate the relative vitamin A equivalency of beta-carotene from the two different preparations of OFSP (boiled or fried).

Secondary purposes are to assess the effect of daily consumption of OFSP on intestinal absorption of iron and zinc. Specifically, 120 non-pregnant, non-lactating women at risk of vitamin A deficiency will be randomly assigned to one of the following 4 treatment groups to receive, 600 micrograms RAE/d, 6 d/wk, for 60 days as either:

  1. boiled OFSP
  2. fried OFSP
  3. retinyl palmitate, or 0 micrograms RAE/d as white-fleshed sweet potato (WFSP)

The paired stable isotope dilution technique will be used to estimate total body vitamin A pool size before and after 60-days of supplementation. The efficacy of consumption of OFSP will be assessed by comparing the mean change in vitamin A pool size in the OFSP groups to the mean change in vitamin A pool size in the negative control group (WFSP group). Relative vitamin A equivalency factors will be estimated by comparing the mean change in vitamin A pool size in the OFSP groups with the mean change in vitamin A pool size in the retinyl palmitate group. Intestinal iron absorption and iron status will be assessed before and after the 60-day supplementation period in a subset of women (n=50); and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period (n=50). Intestinal absorption of iron and zinc will be compared by treatment group to determine whether consumption of OFSP has any effect on iron or zinc absorption in these women.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  • Lactating
  • Diarrhea within past week
  • Severe anemia (< 9g Hb/dL)
  • Symptoms of nightblindness
  • Clinical symptoms of xerophthalmia
  • Chronic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453648

Sponsors and Collaborators
University of California, Davis
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: 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
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marjorie Haskell, Univeristy of California, Davis
ClinicalTrials.gov Identifier: NCT00453648     History of Changes
Other Study ID Numbers: Harvest Plus 8025, Harvest Plus 8027, Harvest Plus 8033
Study First Received: March 27, 2007
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
stable isotopes
vitamin A
beta-carotene
orange-fleshed sweet potatoes
iron
zinc
absorption
bioavailability
vitamin A equivalency
Bangladesh
women

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014