Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitamin A Deficiency

Intervention / Treatment
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* Other: 0 mg retinol activity equivalents
* Other: 12 mg of BC
* Other: 6 mg of CX
* Other: 1.0 mg RAE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactation, cryptoxanthin, beta-carotene, vitamin A