Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin A Deficiency
• Intervention / Treatment: Other: 0 mg retinol activity equivalents; Other: 12 mg of BC; Other: 6 mg of CX; Other: 1.0 mg RAE

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • International Centre for Diarrhoeal Disease Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0 mg retinol; 0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule	Other: 0 mg retinol activity equivalents; 0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
Experimental: 12 mg BC; 12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule.	Other: 12 mg of BC; 12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
Experimental: 6 mg of CX; 6 mg of CX as tangerines and a corn oil capsule	Other: 6 mg of CX; 6 mg of CX as tangerines and a corn oil capsule
Experimental: 1.0 mg RAE; 1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes	Other: 1.0 mg RAE; 1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dark adaptation	Dark adaptation will be measured by the pupillary threshold (PT) test on the first and 3rd weeks of the study.	1 and 3 weeks

Collaborators and Investigators

• Sponsor: USDA, Western Human Nutrition Research Center
• Collaborators: University of California, Davis
• Investigators: Principal Investigator: Betty J Burri, PhD, WHNRC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 17, 2011
• First Submitted That Met QC Criteria: August 18, 2011
• First Posted (Estimate): August 19, 2011

Study Record Updates

• Last Update Posted (Estimate): September 12, 2012
• Last Update Submitted That Met QC Criteria: September 11, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: lactation; vitamin A; cryptoxanthin; beta-carotene
• Additional Relevant MeSH Terms: Eye Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Night Blindness; Vitamin A Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: WHNRC 200816672