Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

Not Applicable

Completed

• Conditions: Vitamin A Deficiency
• Interventions: Other: 6 mg of CX; Other: 12 mg of BC; Other: 0 mg retinol activity equivalents; Other: 1.0 mg RAE

• Registration Number: NCT01420406
• Lead Sponsor: USDA, Western Human Nutrition Research Center

Brief 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.

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 Timeline

• Study Start: 2010-06
• Primary Completion: 2011-05
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Study Completion: 2012-06
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in carotenoids in serum and breast milk	1 and 3 weeks	We will measure serum and breast milk beta-carotene, beta-cryptoxanthin, other carotenoids, and vitamins A and E.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research; 🇧🇩 Dhaka, Bangladesh