Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01420406
First received: August 17, 2011
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Vitamin A Deficiency
Other: 0 mg retinol activity equivalents
Other: 12 mg of BC
Other: 6 mg of CX
Other: 1.0 mg RAE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Change in carotenoids in serum and breast milk [ Time Frame: 1 and 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 and 3 weeks ] [ Designated as safety issue: No ]
    Dark adaptation will be measured by the pupillary threshold (PT) test on the first and 3rd weeks of the study.


Enrollment: 140
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0 mg retinol
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
Other: 0 mg retinol activity equivalents
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
Experimental: 12 mg BC
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule.
Other: 12 mg of BC
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
Experimental: 6 mg of CX
6 mg of CX as tangerines and a corn oil capsule
Other: 6 mg of CX
6 mg of CX as tangerines and a corn oil capsule
Experimental: 1.0 mg RAE
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
Other: 1.0 mg RAE
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420406

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research
Dhaka, Bangladesh
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
University of California, Davis
Investigators
Principal Investigator: Betty J Burri, PhD WHNRC
  More Information

No publications provided by USDA, Western Human Nutrition Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01420406     History of Changes
Other Study ID Numbers: WHNRC 200816672
Study First Received: August 17, 2011
Last Updated: September 11, 2012
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
lactation
cryptoxanthin
beta-carotene
vitamin A

Additional relevant MeSH terms:
Vitamin A Deficiency
Night Blindness
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Beta Carotene
Retinol palmitate
Cryptoxanthin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014