AgingNCT00094042
Work and Iron Status Evaluation
A study testing Iron Supplement, 120mg in people with Aging, run by National Institute on Aging (NIA) at 1 site in Indonesia.
Trial summary
This project seeks to understand how changes in the health of an individual affects the economic and social prosperity of the individual, family and community. The study involves providing iron supplements to a sample of participants in Central Java Indonesia and following those respondents for three years. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Iron Supplement, 120mg
- How many people
- 16,000 participants
- Where
- 1 siteIndonesia
- Study dates
- Jan 2002to Jul 2007
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident in village in study area in Purworejo District, Central Java, Indonesia
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Work and Iron Status Evaluation (WISE)
This project seeks to understand how changes in the health of an individual affects the economic and social prosperity of the individual, family and community. The study involves providing iron supplements to a sample of participants in Central Java Indonesia and following those respondents for three years. They are compared with a control group who do not receive the supplement.
Read the detailed description
The goal of the study is to pin down the causal effect of improvements in health on the economic and social prosperity of individuals and their families. Particular attention will be paid to the dynamics underlying the effect of health on labor outcomes; older adults are more likely to experience transitions in health and economic status and so will be emphasized.
Beginning in 2002, about 4,000 households will be interviewed every four months for about 3 years. The first two waves of the survey will serve as baselines. After the second wave, households will be randomly assigned to one of two groups. Iron supplements will be provided to all members of households assigned to one of those groups. Household members in the 2nd group will receive an identical-looking placebo. Participants will take the supplements (or placebo) on a weekly basis for a year. The study will measure the effect of supplementation on the well-being of individuals and their families.
Data will be collected at the individual, household and community level. Individual level data will cover time allocation including work and participation in community activities, earnings, self-reported and physical health and cognition. All adult household members will be interviewed; questions about children will be answered by a caretaker. Data on wealth and consumption will be collected at the household level. Community resources, services and infrastructure information will be gathered along with detailed price data.
- Conditions
- Aging
- Being tested
- Iron Supplement, 120mg
- Keywords
- Socioeconomic Factors, Dietary Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Supplement, 120mgDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2004 (estimated)
- Study startJan 2002
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 16,000 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Duncan Thomas, Principal investigator, Department of Economics, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094042
- Sponsor's protocol ID
- AG0007
- Other IDs
- 5R01AG020909-04
- Status last verified
- Aug 2008
- First submitted
- 8 Oct 2004
- Last updated
- 27 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work and Iron Status Evaluation (WISE)
- ClinicalTrials.gov ID
- NCT00094042
- Acronym / sponsor ID
- AG0007
- Conditions
- Aging
- Keywords
- Socioeconomic Factors, Dietary Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,000 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Jan 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 11 Oct 2004 (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.
This project seeks to understand how changes in the health of an individual affects the economic and social prosperity of the individual, family and community. The study involves providing iron supplements to a sample of participants in Central Java Indonesia and following those respondents for three years. They are compared with a control group who do not receive the supplement.
Detailed description
The goal of the study is to pin down the causal effect of improvements in health on the economic and social prosperity of individuals and their families. Particular attention will be paid to the dynamics underlying the effect of health on labor outcomes; older adults are more likely to experience transitions in health and economic status and so will be emphasized.
Beginning in 2002, about 4,000 households will be interviewed every four months for about 3 years. The first two waves of the survey will serve as baselines. After the second wave, households will be randomly assigned to one of two groups. Iron supplements will be provided to all members of households assigned to one of those groups. Household members in the 2nd group will receive an identical-looking placebo. Participants will take the supplements (or placebo) on a weekly basis for a year. The study will measure the effect of supplementation on the well-being of individuals and their families.
Data will be collected at the individual, household and community level. Individual level data will cover time allocation including work and participation in community activities, earnings, self-reported and physical health and cognition. All adult household members will be interviewed; questions about children will be answered by a caretaker. Data on wealth and consumption will be collected at the household level. Community resources, services and infrastructure information will be gathered along with detailed price data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident in village in study area in Purworejo District, Central Java, Indonesia
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Iron Supplement, 120mg | Drug | – |
Primary outcome
Not reported in the source record.
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 27 Jan 2010.
- Work and Iron Status EvaluationLink 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.
Duncan Thomas principal investigator
Department of Economics, UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Supplement, 120mg in people with Aging, run by National Institute on Aging (NIA) at 1 site in Indonesia.
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 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 27 Jan 2010. 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 Indonesia. 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.
Where can I read the original study information?
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 27 Jan 2010.