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Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

Primary Purpose

Vitamin A Deficiency

Status

Completed

Phase

Not Applicable

Locations

Bangladesh

Study Type

Interventional

Intervention

0 mg retinol activity equivalents

12 mg of BC

6 mg of CX

1.0 mg RAE

About this trial

This is an interventional basic science trial for Vitamin A Deficiency focused on measuring lactation, cryptoxanthin, beta-carotene, vitamin A

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

International Centre for Diarrhoeal Disease Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

0 mg retinol

12 mg BC

6 mg of CX

1.0 mg RAE

Arm Description

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

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

6 mg of CX as tangerines and a corn oil capsule

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Dark adaptation

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

Full Information

NCT ID

NCT01420406

First Posted

August 17, 2011

Last Updated

September 11, 2012

Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

University of California, Davis

1. Study Identification

Unique Protocol Identification Number

NCT01420406

Brief Title

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

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

University of California, Davis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin A Deficiency

Keywords

lactation, cryptoxanthin, beta-carotene, vitamin A

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0 mg retinol

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

12 mg BC

Arm Type

Experimental

Arm Description

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

Arm Title

6 mg of CX

Arm Type

Experimental

Arm Description

6 mg of CX as tangerines and a corn oil capsule

Arm Title

1.0 mg RAE

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

0 mg retinol activity equivalents

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

12 mg of BC

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

6 mg of CX

Intervention Description

6 mg of CX as tangerines and a corn oil capsule

Intervention Type

Other

Intervention Name(s)

1.0 mg RAE

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in carotenoids in serum and breast milk

Description

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 Outcome Measure Information:

Title

Change in Dark adaptation

Description

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Betty J Burri, PhD

Organizational Affiliation

WHNRC

Official's Role

Principal Investigator

Facility Information:

Facility Name

International Centre for Diarrhoeal Disease Research

City

Dhaka

Country

Bangladesh

12. IPD Sharing Statement

Citations:

PubMed Identifier

24004891

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.

Results Reference

derived

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Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

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