AnemiaNCT03251664
Food Groups Associated With Anaemia in Pregnant Women
An observational study of Anemia and Dietary Habits, run by Tehran University of Medical Sciences at 1 site in Ethiopia.
Trial summary
This study investigates the association between locally consumed food items with anemia among pregnant women, in Addis Ababa city, Ethiopia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anemia, Dietary Habits, Food Habits
- What is being tested?
- Food groups consumed
- How many people
- 592 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Oct 2015to 20 Feb 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Adult
Study population: Pregnant women in Addis Ababa city, Ethiopia
Who may be able to join
- Pregnant women
- Age 18 years and above
- Residence in Addis Ababa city
Who cannot join
- Serious medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relation of Locally Available Food Items With Anemia Status Among Pregnant Women in Ethiopia
This study investigates the association between locally consumed food items with anemia among pregnant women, in Addis Ababa city, Ethiopia.
Read the detailed description
Prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda in Ethiopia. Anemia is a significant contributor to poor pregnancy outcomes, including low birth weight and maternal mortality. Anemia is of multiple influences, which in most of the cases include dietary factors. Consumption food items rich in iron and other nutrients involved in red blood cell production promotes optimal hemoglobin level. Dark green leafy vegetables, meat, and beans are some of the food groups reported to be associated with lesser risk of anemia. Studies on the relation of indigenous food items with health outcome are limited in developing countries. For example, teff, consumed only in Ethiopia and parts of Eritrea, is traditionally believed to be protective of anemia because of its high iron content, but Khat chewing, a pervasive social practice in Ethiopia, has been associated with restrictive eating pattern and anemia. In this study, the association of locally consumed food groups with anemia was investigated among pregnant Ethiopian women.
- Conditions
- Anemia, Dietary Habits, Food Habits
- Being tested
- Food groups consumed
- Medical subject headings
- Anemia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food groups consumedDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Anemic | Hemoglobin <11 g/l Receives: Dietary Supplement: Food groups consumed | |
| Non-anemic | Hemoglobin 11 g/l (and above) Receives: Dietary Supplement: Food groups consumed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food items/groups association with anemia
Relation of food groups with anemia risk
Measured: October 2015 to February 2016
Secondary outcomes (2)
Reproductive factors associated with anemia
Relation of reproductive and obstetrics history with anemia
Measured: October 2015 to February 2016
Sociodemographic and economic factors association with anemia
Relation of socioeconomic factors with anemia
Measured: October 2015 to February 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Oct 2015
- Primary completion20 Feb 2016
- Study completion20 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 592 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimels Hussien Mohammed, Tehran University of Medical Sciences
- Investigators
- Ahmad Esmaillzadeh, PhD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251664
- Sponsor's protocol ID
- AAHB-217/15
- Status last verified
- Aug 2017
- First submitted
- 12 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided.
Publications
Mohammed SH, Taye H, Larijani B, Esmaillzadeh A. Food taboo among pregnant Ethiopian women: magnitude, drivers, and association with anemia. Nutr J. 2019 Mar 23;18(1):19. doi: 10.1186/s12937-019-0444-4.
PubMed 30904017Mohammed SH, Taye H, Sissay TA, Larijani B, Esmaillzadeh A. Teff consumption and anemia in pregnant Ethiopian women: a case-control study. Eur J Nutr. 2019 Aug;58(5):2011-2018. doi: 10.1007/s00394-018-1759-1. Epub 2018 Jun 23.
PubMed 29936535
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation of Locally Available Food Items With Anemia Status Among Pregnant Women in Ethiopia
- ClinicalTrials.gov ID
- NCT03251664
- Acronym / sponsor ID
- AAHB-217/15
- Conditions
- Anemia, Dietary Habits, Food Habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 20 Feb 2016 (actual)
- Study completion
- 20 Feb 2016 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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.
This study investigates the association between locally consumed food items with anemia among pregnant women, in Addis Ababa city, Ethiopia.
Detailed description
Prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda in Ethiopia. Anemia is a significant contributor to poor pregnancy outcomes, including low birth weight and maternal mortality. Anemia is of multiple influences, which in most of the cases include dietary factors. Consumption food items rich in iron and other nutrients involved in red blood cell production promotes optimal hemoglobin level. Dark green leafy vegetables, meat, and beans are some of the food groups reported to be associated with lesser risk of anemia. Studies on the relation of indigenous food items with health outcome are limited in developing countries. For example, teff, consumed only in Ethiopia and parts of Eritrea, is traditionally believed to be protective of anemia because of its high iron content, but Khat chewing, a pervasive social practice in Ethiopia, has been associated with restrictive eating pattern and anemia. In this study, the association of locally consumed food groups with anemia was investigated among pregnant Ethiopian women.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anemic | – | Dietary Supplement: Food groups consumedHemoglobin <11 g/l |
| Non-anemic | – | Dietary Supplement: Food groups consumedHemoglobin 11 g/l (and above) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women in Addis Ababa city, Ethiopia
Key inclusion criteria (3 listed)
- Pregnant women
- Age 18 years and above
- Residence in Addis Ababa city
Key exclusion criteria (1 listed)
- Serious medical illness
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 |
|---|---|---|
| Food groups consumed | Dietary supplement | Anemic, Non-anemic |
Primary outcome
Food items/groups association with anemia
Time frame: October 2015 to February 2016
Relation of food groups with anemia risk
2 secondary outcomes
Reproductive factors associated with anemia
Time frame: October 2015 to February 2016
Sociodemographic and economic factors association with anemia
Time frame: October 2015 to February 2016
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 22 Aug 2017.
- Derived from this study: PubMed 30904017Mohammed SH, Taye H, Larijani B, Esmaillzadeh A. Food taboo among pregnant Ethiopian women: magnitude, drivers, and association with anemia. Nutr J. 2019 Mar 23;18(1):19. doi: 10.1186/s12937-019-0444-4.
- Derived from this study: PubMed 29936535Mohammed SH, Taye H, Sissay TA, Larijani B, Esmaillzadeh A. Teff consumption and anemia in pregnant Ethiopian women: a case-control study. Eur J Nutr. 2019 Aug;58(5):2011-2018. doi: 10.1007/s00394-018-1759-1. Epub 2018 Jun 23.
- Individual participant dataSharing planned: Undecided. Not yet decided.
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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.
Ahmad Esmaillzadeh, PhD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Dietary Habits, run by Tehran University of Medical Sciences at 1 site in Ethiopia.
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 3 inclusion and 1 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 22 Aug 2017. 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 Ethiopia. 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. 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?
Food items/groups association with anemia (time frame: October 2015 to February 2016). 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 NCT03251664, which also lists 2 linked publications.
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 22 Aug 2017.