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Completed

NCT Number: NCT01420406

Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

About this study

The specific aim is to compare the effects of orange-fleshed sweet potatoes and tangerines compared to white-fleshed sweet potatoes and vitamin A as retinyl palmitate on blood and breast milk cryptoxanthin (CX), beta-carotene (BC), and vitamin A (VA) concentrations by randomly assigning lactating Bangladeshi women to one of four treatment groups for 6 days/week for 3 weeks.

The investigators will also compare the relative vitamin A (VA) value of BC and CX from food sources by comparing the mean change in breast milk retinol concentrations of the groups that receive tangerines (CX) or orange-fleshed sweet potatoes (BC) with the mean change in breast milk retinol of the group that receives retinyl palmitate.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Health status is not compatible with the inclusion criteria, such as screening blood chemistries indicative of vitamin A deficiency.
  • 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

Treatment and study plan

0 mg retinol activity equivalents

Other

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

12 mg of BC

Other

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

6 mg of CX

Other

6 mg of CX as tangerines and a corn oil capsule

1.0 mg RAE

Other

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

Primary outcomes

  1. Change in carotenoids in serum and breast milk

    Time frame: 1 and 3 weeks

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

Secondary outcomes

  1. Change in Dark adaptation

    Time frame: 1 and 3 weeks

    Dark adaptation will be measured by the pupillary threshold (PT) test on the first and 3rd weeks of the study.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • University of California, Davis

Registry information

Official study title

Impact of Daily Feeding of Food Sources of Cryptoxanthin (CX) and Beta-carotene (BC) on Plasma and Breast Milk Concentrations of CX, BC, and Retinol (VA) in Lactating Women With Marginal Vitamin A Status

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 19, 2011
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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