Vitamin A DeficiencyNCT01420406
Vitamin A Bioavailability in Lactating Women With Marginal Vitamin A Status
A study testing 0 mg retinol activity equivalents, 12 mg of BC and 6 mg of CX in people with Vitamin A Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- 0 mg retinol activity equivalents, 12 mg of BC and 6 mg of CX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteBangladesh
- Study dates
- Jun 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research
Dhaka
About this study
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
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.
Read the 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.
- Conditions
- Vitamin A Deficiency
- Being tested
- 0 mg retinol activity equivalents, 12 mg of BC, 6 mg of CX, 1.0 mg RAE
- Keywords
- lactation, cryptoxanthin, beta-carotene, vitamin A
- Medical subject headings
- Vitamin A Deficiency, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 mg retinol activity equivalentsOther
0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
12 mg of BCOther
12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
6 mg of CXOther
6 mg of CX as tangerines and a corn oil capsule
1.0 mg RAEOther
1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
| Study group | Role | What they receive |
|---|---|---|
| 0 mg retinol | Placebo comparator | 0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule Receives: Other: 0 mg retinol activity equivalents |
| 12 mg BC | Experimental | 12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule. Receives: Other: 12 mg of BC |
| 6 mg of CX | Experimental | 6 mg of CX as tangerines and a corn oil capsule Receives: Other: 6 mg of CX |
| 1.0 mg RAE | Experimental | 1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes Receives: Other: 1.0 mg RAE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 and 3 weeks
Secondary outcomes (1)
Change in Dark adaptation
Dark adaptation will be measured by the pupillary threshold (PT) test on the first and 3rd weeks of the study.
Measured: 1 and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startJun 2010
- Primary completionMay 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Betty J Burri, PhD, Principal investigator, WHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420406
- Sponsor's protocol ID
- WHNRC 200816672
- Status last verified
- Sep 2012
- First submitted
- 17 Aug 2011
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24004891
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01420406
- Acronym / sponsor ID
- WHNRC 200816672
- Conditions
- Vitamin A Deficiency
- Keywords
- lactation, cryptoxanthin, beta-carotene, vitamin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis
- Study start
- Jun 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 mg retinol | Placebo comparator | Other: 0 mg retinol activity equivalents0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule |
| 12 mg BC | Experimental | Other: 12 mg of BC12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule. |
| 6 mg of CX | Experimental | Other: 6 mg of CX6 mg of CX as tangerines and a corn oil capsule |
| 1.0 mg RAE | Experimental | Other: 1.0 mg RAE1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0 mg retinol activity equivalents0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule | Other | 0 mg retinol |
| 12 mg of BC12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule | Other | 12 mg BC |
| 6 mg of CX6 mg of CX as tangerines and a corn oil capsule | Other | 6 mg of CX |
| 1.0 mg RAE1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes | Other | 1.0 mg RAE |
Primary outcome
Change in carotenoids in serum and breast milk
Time frame: 1 and 3 weeks
We will measure serum and breast milk beta-carotene, beta-cryptoxanthin, other carotenoids, and vitamins A and E.
1 secondary outcome
Change in Dark adaptation
Time frame: 1 and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
- Derived from this study: PubMed 24004891Turner 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.
- USDA Western Human Nutrition Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betty J Burri, PhD principal investigator
WHNRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0 mg retinol activity equivalents, 12 mg of BC and 6 mg of CX in people with Vitamin A Deficiency, run by USDA, Western Human Nutrition Research Center at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in carotenoids in serum and breast milk (time frame: 1 and 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2012.