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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:
ClinicalTrials.gov Identifier:
NCT00453648
First Posted: March 29, 2007
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
International Centre for Diarrhoeal Disease Research, Bangladesh
Information provided by (Responsible Party):
University of California, Davis
  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 Other: White-fleshed sweet potatoes Other: Orange-fleshed sweet potatoes (boiled) Other: Orange-fleshed sweet potatoes (fried) Other: WFSP and capsule of retinyl palmitate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • Iron absorption [ Time Frame: 3 years ]

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)
Arms Assigned Interventions
Placebo Comparator: White-fleshed Sweet Potato
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
Experimental: Orange-fleshed Sweet Potato (boiled)
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)
Experimental: Orange-fleshed Sweet Potato (fried)
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)
Active Comparator: White-fleshed Sweet Potato and retinyl palmitate capsule
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00453648     History of Changes
Other Study ID Numbers: 200513770
Harvest Plus 8027 ( Other Grant/Funding Number: Harvest Plus Program )
Harvest Plus 8033 ( Other Grant/Funding Number: Harvest Plus Program )
First Submitted: March 27, 2007
First Posted: March 29, 2007
Last Update Posted: May 30, 2017
Last Verified: May 2017

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
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents