Iron Deficiency AnemiaPhase 3NCT00276198
Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
A Phase 3 study testing Sprinkles and Ferripel-3, Vitamins A&D drops in people with Iron Deficiency Anemia and Infectious Diseases, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The objective of the program is to examine the efficacy of 6 month home micronutrient supplementation in Bedouin and Jewish children on improvements in nutritional status including measures of iron, ferritin, zinc and folic acid, and measures of growth and health parameters i.e.reported and recorded morbidity. Read more about this study
- Who is it for?
- Ages 5 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Infectious Diseases, Undernutrition
- What is being tested?
- Sprinkles and Ferripel-3, Vitamins A&D drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 771 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2005to Dec 2007
- Phase
- Phase 3
- 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 5 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant aged 5-7 months
- Infant whose parents give their written informed consent
- Infants whose parents intend to reside within the area for at least 12 months
- Infants receiving any additional food besides breast feeding
Who cannot join
- Known or suspected haemotological disorders
- Known or suspected anemia (Hb <11 gr/dl)
- Known or suspected immunological disorders
- Known or suspected malabsorption disorders
- Enrolled or scheduled to be enrolled in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Controlled Clinical Trial to Assess the Effect of Multiple Micronutrient Supplementation (Iron, Vitamins A, C, D, Folic Acid and Zinc) on Nutritional and Health Indicators in Infants in Southern Israel.
The objective of the program is to examine the efficacy of 6 month home micronutrient supplementation in Bedouin and Jewish children on improvements in nutritional status including measures of iron, ferritin, zinc and folic acid, and measures of growth and health parameters i.e.reported and recorded morbidity.
Read the detailed description
The high level of anemia persists in Negev children despite the existence of a policy of the Ministry of Health that calls for Iron, Vitamin A and Vitamin D supplementation up to 12 months of age. In addition, other micronutrient deficiencies in this population have been described in several studies. These may be related to; low adherence with existing recommendations; need for additional micronutrients other than Iron, Vitamin A and Vitamin D; the need for a different delivery system more acceptable to mothers and infants.
We will compare in Bedouin and Jewish children separately the efficacy of daily use of Sprinkles(home Micronutrient fortification) from age 6 to 12 months in infants recruited in Maternal and Child Health clinics.
The comparison will be children recruited in clinics of comparable socioeconomic status, where current Ministry of Health recommendations (drops of iron and vitamins A plus D) are the treatment regimen.
- Conditions
- Iron Deficiency Anemia, Infectious Diseases, Undernutrition
- Being tested
- Sprinkles, Ferripel-3, Vitamins A&D drops
- Keywords
- Clinical trial, controlled, Micronutrients, Dietary Supplementation, Infants
- Medical subject headings
- Anemia, Iron-Deficiency, Communicable Diseases, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SprinklesDietary supplement
Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.
Ferripel-3, Vitamins A&D dropsDietary supplement
Also called oral drops
Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Supplementation with daily sprinkle package Receives: Dietary Supplement: Sprinkles |
| 2 | Active comparator | Supplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations. Receives: Dietary Supplement: Ferripel-3, Vitamins A&D drops |
| 3 | No intervention | No intervention except for checking outcomes at approprite times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)
Measured: 12, 18 and 24 months
Micronutrient status (Iron, Zinc and B12 and Folic acid level)
Measured: 12, 18 months
Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM)
Measured: 12, 18, 24 months
Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations
Measured: 24 months
Secondary outcomes (3)
Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)
Measured: 12, 18, 24 months
Growth parameters (WAZ, HAZ, WHZ)
Measured: 12, 18, 24 months
Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionDec 2007
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 Iron Deficiency 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 771 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Drora Fraser, PhD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276198
- Sponsor's protocol ID
- sor395705ctil
- Status last verified
- Mar 2008
- First submitted
- 11 Jan 2006
- Last updated
- 16 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Fraser D, Shahar D, Shai I, Vardi H, Bilenko N. Negev nutritional studies: nutritional deficiencies in young and elderly populations. Public Health Rev. 2000;28(1-4):31-46.
PubMed 11411276
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trial to Assess the Effect of Multiple Micronutrient Supplementation (Iron, Vitamins A, C, D, Folic Acid and Zinc) on Nutritional and Health Indicators in Infants in Southern Israel.
- ClinicalTrials.gov ID
- NCT00276198
- Acronym / sponsor ID
- sor395705ctil
- Conditions
- Iron Deficiency Anemia, Infectious Diseases, Undernutrition
- Keywords
- Clinical trial, controlled, Micronutrients, Dietary Supplementation, Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 771 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Jan 2006 (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 objective of the program is to examine the efficacy of 6 month home micronutrient supplementation in Bedouin and Jewish children on improvements in nutritional status including measures of iron, ferritin, zinc and folic acid, and measures of growth and health parameters i.e.reported and recorded morbidity.
Detailed description
The high level of anemia persists in Negev children despite the existence of a policy of the Ministry of Health that calls for Iron, Vitamin A and Vitamin D supplementation up to 12 months of age. In addition, other micronutrient deficiencies in this population have been described in several studies. These may be related to; low adherence with existing recommendations; need for additional micronutrients other than Iron, Vitamin A and Vitamin D; the need for a different delivery system more acceptable to mothers and infants.
We will compare in Bedouin and Jewish children separately the efficacy of daily use of Sprinkles(home Micronutrient fortification) from age 6 to 12 months in infants recruited in Maternal and Child Health clinics.
The comparison will be children recruited in clinics of comparable socioeconomic status, where current Ministry of Health recommendations (drops of iron and vitamins A plus D) are the treatment regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: SprinklesSupplementation with daily sprinkle package |
| 2 | Active comparator | Dietary Supplement: Ferripel-3, Vitamins A&D dropsSupplementation with Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms. According to Ministry of Health routine recommendations. |
| 3 | No intervention | –No intervention except for checking outcomes at approprite times. |
Who may qualify
- Ages
- 5 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant aged 5-7 months
- Infant whose parents give their written informed consent
- Infants whose parents intend to reside within the area for at least 12 months
- Infants receiving any additional food besides breast feeding
Key exclusion criteria (5 listed)
- Known or suspected haemotological disorders
- Known or suspected anemia (Hb <11 gr/dl)
- Known or suspected immunological disorders
- Known or suspected malabsorption disorders
- Enrolled or scheduled to be enrolled in another clinical trial
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 |
|---|---|---|
| SprinklesDaily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg. | Dietary supplement | 1 |
| Ferripel-3, Vitamins A&D dropsAlso: oral dropsDaily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months | Dietary supplement | 2 |
Primary outcome
Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)
Time frame: 12, 18 and 24 months
Micronutrient status (Iron, Zinc and B12 and Folic acid level)
Time frame: 12, 18 months
Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM)
Time frame: 12, 18, 24 months
Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations
Time frame: 24 months
3 secondary outcomes
Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)
Time frame: 12, 18, 24 months
Growth parameters (WAZ, HAZ, WHZ)
Time frame: 12, 18, 24 months
Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.
Time frame: 12 months
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 16 Apr 2008.
- Background: PubMed 11411276Fraser D, Shahar D, Shai I, Vardi H, Bilenko N. Negev nutritional studies: nutritional deficiencies in young and elderly populations. Public Health Rev. 2000;28(1-4):31-46.
- The site that describes the intervention treatmentLink 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.
Drora Fraser, PhD principal investigator
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sprinkles and Ferripel-3, Vitamins A&D drops in people with Iron Deficiency Anemia and Infectious Diseases, run by Soroka University Medical Center at 1 site in Israel.
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 4 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 16 Apr 2008. 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 Israel. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Haemotological parameters (haemoglobin, transferrin saturation, and ferritin) (time frame: 12, 18 and 24 months). The study lists 4 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 NCT00276198, 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 16 Apr 2008.