Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Vitamin A Deficiency

Treatments: Other: 1.0 mg RAE; Other: 12 mg of BC; Other: 6 mg of CX; Other: 0 mg retinol activity equivalents

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01420406

WHNRC 200816672

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups, including a placebo group

0 mg retinol

Placebo Comparator group

Description:

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

Treatment:

Other: 0 mg retinol activity equivalents

12 mg BC

Experimental group

Description:

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

Treatment:

Other: 12 mg of BC

6 mg of CX

Experimental group

Description:

6 mg of CX as tangerines and a corn oil capsule

Treatment:

Other: 6 mg of CX

1.0 mg RAE

Experimental group

Description:

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

Treatment:

Other: 1.0 mg RAE