Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

N/ACompletedNCT01420406

USDA, Western Human Nutrition Research Center140 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

140

Conditions

Vitamin A Deficiency

Interventions

0 mg retinol activity equivalentsOTHER

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

12 mg of BCOTHER

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

6 mg of CXOTHER

6 mg of CX as tangerines and a corn oil capsule

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

International Centre for Diarrhoeal Disease Research

Dhaka, Bangladesh

Outcomes

Primary Outcomes

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.

Time frame: 1 and 3 weeks

Secondary Outcomes

Change in Dark adaptation

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

Time frame: 1 and 3 weeks

Data from ClinicalTrials.gov

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