MorbidityNCT00269542
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
A study testing Zinc and iron folic acid - Intervention in people with Morbidity and Mortality, run by Society for Applied Studies.
Trial summary
Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period. Read more about this study
- Who is it for?
- Ages 1 month to 35 monthsHealthy volunteers can take part
- What is being tested?
- Zinc and iron folic acid - Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94,359 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Aug 2003
- 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 1 month to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 1 months to 23 months
- Either sex
- Resident of study area
Who cannot join
- Likely to leave the area during the study period
- Non consent
- Temporary exclusion criteria Illness requiring hospitalization Visible severe wasting. Visibly wasted children will be referred to a hospital for treatment. They will be eligible for enrollment only after effective rehabilitation.
About this study
Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.
Read the detailed description
Objective: Studies in developing countries show substantial reduction in diarrhoea and respiratory morbidity in young children receiving zinc supplementation. The impact of daily zinc supplementation coadministered with iron folic acid in young children on all cause hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to help shape public policy.
Design: Randomised double blind trial
Setting: Low to middle socio-economic urban neighbourhoods of north and north-west Delhi in India
Participants: 94359 subjects aged 1 month to 23 months
Interventions: The subjects were administered dispersible tablets containing one recommended daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months after enrolment.
Main outcome measures: Hospitalisations were captured through passive surveillance of eight hospitals by trained study physicians. Deaths were ascertained through bimonthly visits to households.
Results: A third of the total children had low zinc levels (<60 mg/dL) and one fourth had iron deficiency (haematocrit <33%) at baseline. The proportion zinc deficient was significantly lower post 12 months supplementation, in the zinc and iron folic acid group (difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). Only 7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low haematocrit. Zinc and iron folic acid supplementation had no impact on hospitalisations, overall and cause-specific. The overall death rates were similar in the two groups.
Conclusions: The lack of mortality impact may be real or the findings could have resulted from the use of lower daily zinc dosing than in morbidity prevention trials or an interaction between zinc and iron whereby adding iron, may have adversely affected potential effects of zinc on immune function and morbidity. Future research should address iron and zinc interaction effects on important functional outcomes.
- Being tested
- Zinc and iron folic acid - Intervention, Iron Folic Acid alone - Placebo
- Keywords
- zinc supplementation, hospitalisations, children, mortality, iron folic acid
- Medical subject headings
- Diarrhea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc and iron folic acid - InterventionDrug
The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.
Iron Folic Acid alone - PlaceboDrug
The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Zinc and iron folic acid - Intervention |
| 2 | Placebo comparator | Not described Receives: Drug: Iron Folic Acid alone - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
- to determine the impact of daily oral supplementation of zinc (5 mg per day to infants aged less than 6 months and 10 mg per day to older children) and iron folic acid to children aged 1-23 months for a period of upto 12 months on all-cause mortality,
Measured: 3 monthly home visits
- to determine the impact of daily oral supplementation of zinc and iron folic acid to children 1-23 months for a period of upto 12 months on overall and diarrhea and pneumonia specific hospital admissions.
Measured: 3 monthly home visits
Secondary outcomes (4)
- the proportion of stunted or underweight children at end study
Measured: Baseline and end study after 12 months
- the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study
Measured: Baseline and end study after 12 months
- the mean plasma copper and superoxide dismutase at end study
Measured: Baseline and end study after 12 months
- the mean plasma ferritin and transferrin activity at end study
Measured: Baseline and end study after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startFeb 2002
- Primary completionMar 2003
- Study completionAug 2003
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 MorbidityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94,359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, All India Institute of Medical Sciences
- Investigators
- Maharaj K Bhan, MD, Principal investigator, Professor, Department of Pediatrics, All India Institute of Medical SciencesNita Bhandari, PhD, Principal investigator, Society for Applied Studies, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269542
- Sponsor's protocol ID
- 00002
- Other IDs
- C6-181-429
- Status last verified
- Jun 2008
- First submitted
- 22 Dec 2005
- Last updated
- 1 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhandari N, Taneja S, Mazumder S, Bahl R, Fontaine O, Bhan MK; Zinc Study Group. Adding zinc to supplemental iron and folic acid does not affect mortality and severe morbidity in young children. J Nutr. 2007 Jan;137(1):112-7. doi: 10.1093/jn/137.1.112.
PubMed 17182810
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
- ClinicalTrials.gov ID
- NCT00269542
- Acronym / sponsor ID
- 00002
- Keywords
- zinc supplementation, hospitalisations, children, mortality, iron folic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94,359 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- World Health Organization, All India Institute of Medical Sciences
- Study start
- Feb 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 23 Dec 2005 (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.
Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.
Detailed description
Objective: Studies in developing countries show substantial reduction in diarrhoea and respiratory morbidity in young children receiving zinc supplementation. The impact of daily zinc supplementation coadministered with iron folic acid in young children on all cause hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to help shape public policy.
Design: Randomised double blind trial
Setting: Low to middle socio-economic urban neighbourhoods of north and north-west Delhi in India
Participants: 94359 subjects aged 1 month to 23 months
Interventions: The subjects were administered dispersible tablets containing one recommended daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months after enrolment.
Main outcome measures: Hospitalisations were captured through passive surveillance of eight hospitals by trained study physicians. Deaths were ascertained through bimonthly visits to households.
Results: A third of the total children had low zinc levels (<60 mg/dL) and one fourth had iron deficiency (haematocrit <33%) at baseline. The proportion zinc deficient was significantly lower post 12 months supplementation, in the zinc and iron folic acid group (difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). Only 7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low haematocrit. Zinc and iron folic acid supplementation had no impact on hospitalisations, overall and cause-specific. The overall death rates were similar in the two groups.
Conclusions: The lack of mortality impact may be real or the findings could have resulted from the use of lower daily zinc dosing than in morbidity prevention trials or an interaction between zinc and iron whereby adding iron, may have adversely affected potential effects of zinc on immune function and morbidity. Future research should address iron and zinc interaction effects on important functional outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Zinc and iron folic acid - Intervention |
| 2 | Placebo comparator | Drug: Iron Folic Acid alone - Placebo |
Who may qualify
- Ages
- 1 month to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 1 months to 23 months
- Either sex
- Resident of study area
Key exclusion criteria (3 listed)
- Likely to leave the area during the study period
- Non consent
- Temporary exclusion criteria Illness requiring hospitalization Visible severe wasting. Visibly wasted children will be referred to a hospital for treatment. They will be eligible for enrollment only after effective rehabilitation.
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 |
|---|---|---|
| Zinc and iron folic acid - InterventionThe intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid. | Drug | 1 |
| Iron Folic Acid alone - PlaceboThe control group tablets were similar in composition, appearance and taste except it contained placebo for zinc. | Drug | 2 |
Primary outcome
- to determine the impact of daily oral supplementation of zinc (5 mg per day to infants aged less than 6 months and 10 mg per day to older children) and iron folic acid to children aged 1-23 months for a period of upto 12 months on all-cause mortality,
Time frame: 3 monthly home visits
- to determine the impact of daily oral supplementation of zinc and iron folic acid to children 1-23 months for a period of upto 12 months on overall and diarrhea and pneumonia specific hospital admissions.
Time frame: 3 monthly home visits
4 secondary outcomes
- the proportion of stunted or underweight children at end study
Time frame: Baseline and end study after 12 months
- the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study
Time frame: Baseline and end study after 12 months
- the mean plasma copper and superoxide dismutase at end study
Time frame: Baseline and end study after 12 months
- the mean plasma ferritin and transferrin activity at end study
Time frame: Baseline and end study after 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 1 Jul 2008.
- Background: PubMed 17182810Bhandari N, Taneja S, Mazumder S, Bahl R, Fontaine O, Bhan MK; Zinc Study Group. Adding zinc to supplemental iron and folic acid does not affect mortality and severe morbidity in young children. J Nutr. 2007 Jan;137(1):112-7. doi: 10.1093/jn/137.1.112.
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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.
Maharaj K Bhan, MD principal investigator
Professor, Department of Pediatrics, All India Institute of Medical Sciences
Nita Bhandari, PhD principal investigator
Society for Applied Studies, New Delhi
Questions about this trial
What is this clinical trial studying?
A study testing Zinc and iron folic acid - Intervention in people with Morbidity and Mortality, run by Society for Applied Studies.
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 3 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 1 Jul 2008. 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?
- to determine the impact of daily oral supplementation of zinc (5 mg per day to infants aged less than 6 months and 10 mg per day to older children) and iron folic acid to children aged 1-23 months for a period of upto 12 months on all-cause mortality, (time frame: 3 monthly home visits). 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 NCT00269542, 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 1 Jul 2008.