Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

Vitamin A Deficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420406
• Other study ID #: WHNRC 200816672
• Status: Completed
• Phase: N/A
• First received: August 17, 2011
• Last updated: September 11, 2012
• Start date: June 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Night Blindness
• Vitamin A Deficiency

Intervention

Other:
• 0 mg retinol activity equivalents
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
• 12 mg of BC
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
• 6 mg of CX
6 mg of CX as tangerines and a corn oil capsule
• 1.0 mg RAE
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	University of California, Davis

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No