Nutritional StatusZANENCT01944891
Diet and Nutritional Status of Adolescent Girls in Zambézia, Mozambique
An observational study of Nutritional Status and Diet, run by University of Helsinki at 1 site in Finland.
Trial summary
Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique was collected. A cross-sectional study was carried out in 2010 in two seasons, January-February and May-June. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Diet
- How many people
- 551 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2010to Jun 2010
- 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 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescent girls living in Quelimane city, Maganja da Costa district and Morrumbala district.
Who may be able to join
- Girls in the target age range who were able to visit the study centre and didn't have any significant illness preventing participation were considered eligible.
Who cannot join
- age not between 15 and 18 years
- any apparent significant illness, disability or unstable medical condition which could lead to difficulty participating in the study
- unwillingness to participate in the study
- unwillingness or inability to arrive at the study location at the requested time.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Food and Environmental Science, University of Helsinki
Helsinki, 00014
About this study
Official title: Estudo do Estado Nutricional e da Dieta em Raparigas Adolescentes na Zambézia
Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique was collected. A cross-sectional study was carried out in 2010 in two seasons, January-February and May-June. Participants (total n=551) were recruited from Quelimane (the provincial capital), Maganja da Costa district and Morrumbala district.
- Conditions
- Nutritional Status, Diet
- Keywords
- Adolescent girls, Mozambique, Diet, Anthropometrics, Serum biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood vitamin and mineral concentrations
Measured: cross-sectional 2010, single measurement
Dietary assessment
24-hr recall, food frequency questionnaire
Measured: cross-sectional 2010, single measurement
Secondary outcomes (1)
Diseases (intestinal helminths, malaria parasitemia, HIV-status)
Measured: cross-sectional 2010, single measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startJan 2010
- Primary completionJun 2010
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 Nutritional StatusStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marja Mutanen, University of Helsinki
- Investigators
- Marja L Mutanen, Prof., Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944891
- Sponsor's protocol ID
- 151152
- Acronym
- ZANE
- Status last verified
- Sep 2013
- First submitted
- 30 Aug 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Freese R, Korkalo L, Vessby B, Tengblad S, Vaara EM, Hauta-alus H, Selvester K, Mutanen M. Essential fatty acid intake and serum fatty acid composition among adolescent girls in central Mozambique. Br J Nutr. 2015 Apr 14;113(7):1086-95. doi: 10.1017/S0007114515000306. Epub 2015 Mar 16.
PubMed 25772191Korkalo L, Freese R, Fidalgo L, Selvester K, Ismael C, Mutanen M. A Cross-Sectional Study on the Diet and Nutritional Status of Adolescent Girls in Zambezia Province, Mozambique (the ZANE Study): Design, Methods, and Population Characteristics. JMIR Res Protoc. 2014 Mar 5;3(1):e12. doi: 10.2196/resprot.3109.
PubMed 24598035
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudo do Estado Nutricional e da Dieta em Raparigas Adolescentes na Zambézia
- ClinicalTrials.gov ID
- NCT01944891
- Acronym / sponsor ID
- ZANE / 151152
- Conditions
- Nutritional Status, Diet
- Keywords
- Adolescent girls, Mozambique, Diet, Anthropometrics, Serum biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- First posted
- 18 Sep 2013 (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.
Data on the diet and nutritional status of adolescent girls in Zambézia Province, Mozambique was collected. A cross-sectional study was carried out in 2010 in two seasons, January-February and May-June. Participants (total n=551) were recruited from Quelimane (the provincial capital), Maganja da Costa district and Morrumbala district.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent girls living in Quelimane city, Maganja da Costa district and Morrumbala district.
Key inclusion criteria (1 listed)
- Girls in the target age range who were able to visit the study centre and didn't have any significant illness preventing participation were considered eligible.
Key exclusion criteria (4 listed)
- age not between 15 and 18 years
- any apparent significant illness, disability or unstable medical condition which could lead to difficulty participating in the study
- unwillingness to participate in the study
- unwillingness or inability to arrive at the study location at the requested time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood vitamin and mineral concentrations
Time frame: cross-sectional 2010, single measurement
Dietary assessment
Time frame: cross-sectional 2010, single measurement
24-hr recall, food frequency questionnaire
1 secondary outcome
Diseases (intestinal helminths, malaria parasitemia, HIV-status)
Time frame: cross-sectional 2010, single measurement
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 18 Sep 2013.
- Derived from this study: PubMed 25772191Freese R, Korkalo L, Vessby B, Tengblad S, Vaara EM, Hauta-alus H, Selvester K, Mutanen M. Essential fatty acid intake and serum fatty acid composition among adolescent girls in central Mozambique. Br J Nutr. 2015 Apr 14;113(7):1086-95. doi: 10.1017/S0007114515000306. Epub 2015 Mar 16.
- Derived from this study: PubMed 24598035Korkalo L, Freese R, Fidalgo L, Selvester K, Ismael C, Mutanen M. A Cross-Sectional Study on the Diet and Nutritional Status of Adolescent Girls in Zambezia Province, Mozambique (the ZANE Study): Design, Methods, and Population Characteristics. JMIR Res Protoc. 2014 Mar 5;3(1):e12. doi: 10.2196/resprot.3109.
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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.
Marja L Mutanen, Prof. principal investigator
University of Helsinki
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 Nutritional Status and Diet, run by University of Helsinki at 1 site in Finland.
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 1 inclusion and 4 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 18 Sep 2013. 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 Finland. 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?
Blood vitamin and mineral concentrations (time frame: cross-sectional 2010, single measurement). The study lists 2 primary outcomes in all. 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 NCT01944891, 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 18 Sep 2013.