Vitamin A DeficiencyNCT00453648
Impact of Consumption of Orange-fleshed Sweet Potatoes on the Vitamin A Status of Bangladeshi Women of Reproductive Age
A study testing White-fleshed sweet potatoes, Orange-fleshed sweet potatoes (boiled) and Orange-fleshed sweet potatoes (fried) in people with Vitamin A Deficiency, run by University of California, Davis.
Trial summary
The primary purpose of this study is to determine whether daily consumption of orange-fleshed sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age. 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?
- White-fleshed sweet potatoes, Orange-fleshed sweet potatoes (boiled) and Orange-fleshed sweet potatoes (fried)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Dec 2009
- 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
- Serum retinol concentration < 1.12 umol/L
- Serum C-reactive protein concentration < 10 mg/L
Who cannot join
- Pregnant
- Lactating
- Diarrhea within past week
- Severe anemia (< 9g Hb/dL)
- Symptoms of nightblindness
- Clinical symptoms of xerophthalmia
- Chronic disease
About this study
Official title: Efficacy of Daily Consumption of Sweet Potatoes for Increasing Total Body Vitamin A Pool Size, and the Effect of Consumption of Sweet Potatoes on Iron and Zinc Absorption in Bangladeshi Women of Reproductive Age
The primary purpose of this study is to determine whether daily consumption of orange-fleshed sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age. Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in Bangladeshi women of reproductive age.
Read the detailed description
Biofortification of plant source foods is a promising strategy for increasing dietary vitamin A intake and vitamin A status in populations at risk of deficiency. The primary purposes of this study are:
- to assess the efficacy of daily consumption of boiled or fried orange-fleshed sweet potatoes (OFSP) for increasing the vitamin A status of non-pregnant, non-lactating Bangladeshi women, and
- to estimate the relative vitamin A equivalency of beta-carotene from the two different preparations of OFSP (boiled or fried).
Secondary purposes are to assess the effect of daily consumption of OFSP on intestinal absorption of iron and zinc. Specifically, 120 non-pregnant, non-lactating women at risk of vitamin A deficiency will be randomly assigned to one of the following 4 treatment groups to receive, 600 micrograms RAE/d, 6 d/wk, for 60 days as either:
- boiled OFSP
- fried OFSP
- retinyl palmitate, or 0 micrograms RAE/d as white-fleshed sweet potato (WFSP)
The paired stable isotope dilution technique will be used to estimate total body vitamin A pool size before and after 60-days of supplementation. The efficacy of consumption of OFSP will be assessed by comparing the mean change in vitamin A pool size in the OFSP groups to the mean change in vitamin A pool size in the negative control group (WFSP group). Relative vitamin A equivalency factors will be estimated by comparing the mean change in vitamin A pool size in the OFSP groups with the mean change in vitamin A pool size in the retinyl palmitate group. Intestinal iron absorption and iron status will be assessed before and after the 60-day supplementation period in a subset of women (n=50); and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period (n=50). Intestinal absorption of iron and zinc will be compared by treatment group to determine whether consumption of OFSP has any effect on iron or zinc absorption in these women.
- Conditions
- Vitamin A Deficiency
- Being tested
- White-fleshed sweet potatoes, Orange-fleshed sweet potatoes (boiled), Orange-fleshed sweet potatoes (fried), WFSP and capsule of retinyl palmitate
- Keywords
- stable isotopes, vitamin A, beta-carotene, orange-fleshed sweet potatoes, iron, zinc, absorption, bioavailability, vitamin A equivalency, Bangladesh, women
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White-fleshed sweet potatoesOther
Orange-fleshed sweet potatoes (boiled)Other
Orange-fleshed sweet potatoes (fried)Other
WFSP and capsule of retinyl palmitateOther
| Study group | Role | What they receive |
|---|---|---|
| White-fleshed Sweet Potato | Placebo comparator | 0 ug retinol activity equivalents (RAE)/d as boiled white-fleshed sweet potatoes (WFSP) and a corn oil capsule, 6d/wk for 10 wk Receives: Other: White-fleshed sweet potatoes |
| Orange-fleshed Sweet Potato (boiled) | Experimental | 600 ug RAE/d as boiled orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk Receives: Other: Orange-fleshed sweet potatoes (boiled) |
| Orange-fleshed Sweet Potato (fried) | Experimental | 600 ug RAE/d as fried orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk Receives: Other: Orange-fleshed sweet potatoes (fried) |
| White-fleshed Sweet Potato and retinyl palmitate capsule | Active comparator | 0 ug RAE/d as white-fleshed sweet potato and 600 ug retinol/d as retinyl palmitate, 6d/wk for 10 wk Receives: Other: WFSP and capsule of retinyl palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body vitamin A pool size
Measured: 3 years
Secondary outcomes (1)
Iron absorption
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startMar 2006
- Primary completionDec 2009
- Study completionDec 2009
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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Marjorie J Haskell, PhD, Principal investigator, University of California, DavisKenneth H Brown, MD, Principal investigator, University of California, DavisKazi Jamil, MBBS, PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453648
- Sponsor's protocol ID
- 200513770
- Other IDs
- Harvest Plus 8027, Harvest Plus 8033
- Status last verified
- May 2017
- First submitted
- 27 Mar 2007
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jamil KM, Brown KH, Jamil M, Peerson JM, Keenan AH, Newman JW, Haskell MJ. Daily consumption of orange-fleshed sweet potato for 60 days increased plasma beta-carotene concentration but did not increase total body vitamin A pool size in Bangladeshi women. J Nutr. 2012 Oct;142(10):1896-902. doi: 10.3945/jn.112.164830. Epub 2012 Aug 29.
PubMed 22933750
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Daily Consumption of Sweet Potatoes for Increasing Total Body Vitamin A Pool Size, and the Effect of Consumption of Sweet Potatoes on Iron and Zinc Absorption in Bangladeshi Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT00453648
- Acronym / sponsor ID
- 200513770
- Conditions
- Vitamin A Deficiency
- Keywords
- stable isotopes, vitamin A, beta-carotene, orange-fleshed sweet potatoes, iron, zinc, absorption, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 29 Mar 2007 (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 primary purpose of this study is to determine whether daily consumption of orange-fleshed sweet potatoes increases the vitamin A status of Bangladeshi women of reproductive age. Secondary purposes of the study are to determine whether consumption of orange-fleshed sweet potatoes has an effect on the intestinal absorption of dietary iron or dietary zinc in Bangladeshi women of reproductive age.
Detailed description
Biofortification of plant source foods is a promising strategy for increasing dietary vitamin A intake and vitamin A status in populations at risk of deficiency. The primary purposes of this study are:
- to assess the efficacy of daily consumption of boiled or fried orange-fleshed sweet potatoes (OFSP) for increasing the vitamin A status of non-pregnant, non-lactating Bangladeshi women, and
- to estimate the relative vitamin A equivalency of beta-carotene from the two different preparations of OFSP (boiled or fried).
Secondary purposes are to assess the effect of daily consumption of OFSP on intestinal absorption of iron and zinc. Specifically, 120 non-pregnant, non-lactating women at risk of vitamin A deficiency will be randomly assigned to one of the following 4 treatment groups to receive, 600 micrograms RAE/d, 6 d/wk, for 60 days as either:
- boiled OFSP
- fried OFSP
- retinyl palmitate, or 0 micrograms RAE/d as white-fleshed sweet potato (WFSP)
The paired stable isotope dilution technique will be used to estimate total body vitamin A pool size before and after 60-days of supplementation. The efficacy of consumption of OFSP will be assessed by comparing the mean change in vitamin A pool size in the OFSP groups to the mean change in vitamin A pool size in the negative control group (WFSP group). Relative vitamin A equivalency factors will be estimated by comparing the mean change in vitamin A pool size in the OFSP groups with the mean change in vitamin A pool size in the retinyl palmitate group. Intestinal iron absorption and iron status will be assessed before and after the 60-day supplementation period in a subset of women (n=50); and intestinal zinc absorption and zinc status will be assessed after the 60-day supplementation period (n=50). Intestinal absorption of iron and zinc will be compared by treatment group to determine whether consumption of OFSP has any effect on iron or zinc absorption in these women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| White-fleshed Sweet Potato | Placebo comparator | Other: White-fleshed sweet potatoes0 ug retinol activity equivalents (RAE)/d as boiled white-fleshed sweet potatoes (WFSP) and a corn oil capsule, 6d/wk for 10 wk |
| Orange-fleshed Sweet Potato (boiled) | Experimental | Other: Orange-fleshed sweet potatoes (boiled)600 ug RAE/d as boiled orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk |
| Orange-fleshed Sweet Potato (fried) | Experimental | Other: Orange-fleshed sweet potatoes (fried)600 ug RAE/d as fried orange-fleshed sweet potato and a corn oil capsule, 6d/wk for 10 wk |
| White-fleshed Sweet Potato and retinyl palmitate capsule | Active comparator | Other: WFSP and capsule of retinyl palmitate0 ug RAE/d as white-fleshed sweet potato and 600 ug retinol/d as retinyl palmitate, 6d/wk for 10 wk |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Serum retinol concentration < 1.12 umol/L
- Serum C-reactive protein concentration < 10 mg/L
Key exclusion criteria (7 listed)
- Pregnant
- Lactating
- Diarrhea within past week
- Severe anemia (< 9g Hb/dL)
- Symptoms of nightblindness
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 |
|---|---|---|
| White-fleshed sweet potatoes | Other | White-fleshed Sweet Potato |
| Orange-fleshed sweet potatoes (boiled) | Other | Orange-fleshed Sweet Potato (boiled) |
| Orange-fleshed sweet potatoes (fried) | Other | Orange-fleshed Sweet Potato (fried) |
| WFSP and capsule of retinyl palmitate | Other | White-fleshed Sweet Potato and retinyl palmitate capsule |
Primary outcome
Total body vitamin A pool size
Time frame: 3 years
1 secondary outcome
Iron absorption
Time frame: 3 years
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 30 May 2017.
- Derived from this study: PubMed 22933750Jamil KM, Brown KH, Jamil M, Peerson JM, Keenan AH, Newman JW, Haskell MJ. Daily consumption of orange-fleshed sweet potato for 60 days increased plasma beta-carotene concentration but did not increase total body vitamin A pool size in Bangladeshi women. J Nutr. 2012 Oct;142(10):1896-902. doi: 10.3945/jn.112.164830. Epub 2012 Aug 29.
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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.
Marjorie J Haskell, PhD principal investigator
University of California, Davis
Kenneth H Brown, MD principal investigator
University of California, Davis
Kazi Jamil, MBBS, PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
Questions about this trial
What is this clinical trial studying?
A study testing White-fleshed sweet potatoes, Orange-fleshed sweet potatoes (boiled) and Orange-fleshed sweet potatoes (fried) in people with Vitamin A Deficiency, run by University of California, Davis.
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 2 inclusion and 7 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Total body vitamin A pool size (time frame: 3 years). 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 NCT00453648, 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 30 May 2017.