Clinical trial NCT01420406: Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin A Deficiency
Keywords: lactation
cryptoxanthin
beta-carotene
vitamin A
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: University of California, Davis
First posted: 2011-08-19
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in carotenoids in serum and breast milk
timeFrame: 1 and 3 weeks
Secondary outcomes:
measure: Change in Dark adaptation
timeFrame: 1 and 3 weeks
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research
Study officials:
affiliation: WHNRC
name: Betty J Burri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turner T, Burri BJ, Jamil KM, Jamil M. The effects of daily consumption of beta-cryptoxanthin-rich tangerines and beta-carotene-rich sweet potatoes on vitamin A and carotenoid concentrations in plasma and breast milk of Bangladeshi women with low vitamin A status in a randomized controlled trial. Am J Clin Nutr. 2013 Nov;98(5):1200-8. doi: 10.3945/ajcn.113.058180. Epub 2013 Sep 4.