DiarrheaNCT00272142
Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial
A study testing Zinc in people with Diarrhea and Respiratory Infection, run by Society for Applied Studies at 1 site in India.
Trial summary
There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes. Read more about this study
- Who is it for?
- Ages 14 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Respiratory Infection, Low Birth Weight
- What is being tested?
- Zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2005to Aug 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 14 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (<10th percentile of the National Center for Health Statistics [NCHS] median birth weight)
- Either sex
- Resides within 7 km of the hospital
Who cannot join
- Likely to leave the area of residence within 6 months of enrollment
- Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
- Non consent for participation
- Illness requiring hospitalization
- Twins
- Preterm
Trial locations and contacts
1 site in 1 country.
India1 site
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110017
About this study
There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes.
The current view of the medical and public health community in India is that the immediate focus should be on promoting survival and development of low birth weight infants who have nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight.
Read more
Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2 recommended dietary allowance [RDA]) reduces incidence of all episodes of diarrhea, severe diarrhea and pneumonia. A number of initial published trials also show significant effect of zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on the incidence and severity of infections, an effect on child mortality is likely.
Available literature suggests the distinct possibility of reduced neonatal and infant mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54% reduction in mortality in LBW infants. These findings were based on a very small sample and therefore considered insufficient to change policy.
A positive impact in the proposed study will provide an important tool for reduction of infant mortality which is currently stagnant and government acceptance for such a program is likely to be very high. We, the researchers at the Society for Applied Studies, believe this study has the potential for decreasing infant mortality from its current level.
Read the detailed description
A double blind, randomized, placebo controlled trial is being conducted in which the unit of randomization is 14-28 days old infants. Infants in the intervention group receive 1 RDA of elemental zinc compared to placebo in the control group, from the day of enrollment till 12 months of age.
Infants for enrollment are being identified through daily screening of newborns in two hospitals. Eligible infants are visited at home for enrollment when aged 14-28 days. The mother is trained in supplement administration. A total of 2000 infants will be enrolled.
Infants in the intervention group are being administered a dispersible tablet daily containing 1 RDA of elemental zinc (5 mg elemental zinc per day in infants aged 14 days to 6 months and 10 mg per day for infants older than 6 months) daily till 12 months of age. The placebo contains plain glucose but is similar in taste, color and consistency to the zinc tablet. The tablets are packaged in strips containing 15 tablets each.
Monthly supplies of the supplement are given to the caregiver to be kept at home. The supplement is administered by the caregiver (usually the mother) herself and the method of administration is taught at the time of enrollment. At the end of every four weeks the monitor collects the strips for the previous month and records the supplement intake for the previous month by examining the strips and querying the caregiver.
Three monthly morbidity visits are conducted by a field investigator to obtain information on the hospitalizations and their causes in the last 3 months, healthcare provider visits in the last 1 month, illnesses for which these were made and severity of these illnesses, diarrhea and respiratory morbidity in the previous 24 hours, week and month. If the infant has been hospitalized in the last 3 months, a hospitalization form is filled to ascertain the reason for hospitalization. In case of deaths, an interview is conducted with the caregiver and a verbal autopsy form is filled.
Blood specimens for estimation of plasma zinc, copper and ferritin are being obtained in 15% randomly selected children at baseline and at end study.
Weights and lengths are being obtained in a subset of children at birth, 3, 6, 9 and 12 months.
- Conditions
- Diarrhea, Respiratory Infection, Low Birth Weight
- Being tested
- Zinc, Placebo
- Keywords
- mortality, hospitalization, diarrhea, respiratory infection, low birth weight, morbidity
- Medical subject headings
- Diarrhea, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause hospitalizations in comparison to infants receiving placebo.
Measured: November 2004 to August 2007
illnesses requiring visits to healthcare providers.
Measured: November 2004 to August 2007
Secondary outcomes (6)
cause specific hospitalizations for diarrhea and acute lower respiratory infections
Measured: November 2004 to August 2007
cause specific health care provider visits for illness
Measured: November 2004 to August 2007
all cause mortality in the two groups
Measured: November 2004 to August 2007
the proportion of stunted or underweight infants at end study
Measured: November 2004 to August 2007
plasma zinc in a subgroup
Measured: November 2004 to August 2007
prevalence of diarrheal and respiratory morbidity
Measured: November 2004 to August 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startJan 2005
- Primary completionAug 2007
- Study completionAug 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 DiarrheaStudies 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
- Factorial
- Masking
- Double blind
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Linda and Kenneth Pollin Foundation, Inc.
- Investigators
- Nita Bhandari, PhD, Principal investigator, Society for Applied Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272142
- Sponsor's protocol ID
- HNI 04002
- Other IDs
- C6.181.488
- Status last verified
- Sep 2009
- First submitted
- 3 Jan 2006
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Taneja S, Bhandari N, Rongsen-Chandola T, Mahalanabis D, Fontaine O, Bhan MK. Effect of zinc supplementation on morbidity and growth in hospital-born, low-birth-weight infants. Am J Clin Nutr. 2009 Aug;90(2):385-91. doi: 10.3945/ajcn.2009.27707. Epub 2009 Jun 24.
PubMed 19553296
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00272142
- Acronym / sponsor ID
- HNI 04002
- Conditions
- Diarrhea, Respiratory Infection, Low Birth Weight
- Keywords
- mortality, hospitalization, diarrhea, respiratory infection, low birth weight, morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- World Health Organization, Linda and Kenneth Pollin Foundation, Inc.
- Study start
- Jan 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 4 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.
There are currently no interventions available to substantially reduce the incidence of low birth weight (LBW) apart from increasing the age at marriage, maternal iron supplementation and possibly improved energy intakes.
The current view of the medical and public health community in India is that the immediate focus should be on promoting survival and development of low birth weight infants who have nearly a 6 to 7 fold higher mortality during infancy than those with normal birth weight.
Low serum zinc is associated with increased incidence of diarrhea and pneumonia. There is sufficient evidence in under-threes that during acute illness, zinc supplementation (1-2 recommended dietary allowance [RDA]) reduces incidence of all episodes of diarrhea, severe diarrhea and pneumonia. A number of initial published trials also show significant effect of zinc treatment on pneumonia. With the large and consistent effects of zinc supplementation on the incidence and severity of infections, an effect on child mortality is likely.
Available literature suggests the distinct possibility of reduced neonatal and infant mortality in LBWs receiving 1 RDA of zinc daily. A pilot study in India showed a 54% reduction in mortality in LBW infants. These findings were based on a very small sample and therefore considered insufficient to change policy.
A positive impact in the proposed study will provide an important tool for reduction of infant mortality which is currently stagnant and government acceptance for such a program is likely to be very high. We, the researchers at the Society for Applied Studies, believe this study has the potential for decreasing infant mortality from its current level.
Detailed description
A double blind, randomized, placebo controlled trial is being conducted in which the unit of randomization is 14-28 days old infants. Infants in the intervention group receive 1 RDA of elemental zinc compared to placebo in the control group, from the day of enrollment till 12 months of age.
Infants for enrollment are being identified through daily screening of newborns in two hospitals. Eligible infants are visited at home for enrollment when aged 14-28 days. The mother is trained in supplement administration. A total of 2000 infants will be enrolled.
Infants in the intervention group are being administered a dispersible tablet daily containing 1 RDA of elemental zinc (5 mg elemental zinc per day in infants aged 14 days to 6 months and 10 mg per day for infants older than 6 months) daily till 12 months of age. The placebo contains plain glucose but is similar in taste, color and consistency to the zinc tablet. The tablets are packaged in strips containing 15 tablets each.
Monthly supplies of the supplement are given to the caregiver to be kept at home. The supplement is administered by the caregiver (usually the mother) herself and the method of administration is taught at the time of enrollment. At the end of every four weeks the monitor collects the strips for the previous month and records the supplement intake for the previous month by examining the strips and querying the caregiver.
Three monthly morbidity visits are conducted by a field investigator to obtain information on the hospitalizations and their causes in the last 3 months, healthcare provider visits in the last 1 month, illnesses for which these were made and severity of these illnesses, diarrhea and respiratory morbidity in the previous 24 hours, week and month. If the infant has been hospitalized in the last 3 months, a hospitalization form is filled to ascertain the reason for hospitalization. In case of deaths, an interview is conducted with the caregiver and a verbal autopsy form is filled.
Blood specimens for estimation of plasma zinc, copper and ferritin are being obtained in 15% randomly selected children at baseline and at end study.
Weights and lengths are being obtained in a subset of children at birth, 3, 6, 9 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 14 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (<10th percentile of the National Center for Health Statistics [NCHS] median birth weight)
- Either sex
- Resides within 7 km of the hospital
Key exclusion criteria (6 listed)
- Likely to leave the area of residence within 6 months of enrollment
- Congenital malformations, congenital heart disease, metabolic disorders, renal diseases, etc.
- Non consent for participation
- Illness requiring hospitalization
- Twins
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 | Drug | – |
| Placebo | Drug | – |
Primary outcome
all cause hospitalizations in comparison to infants receiving placebo.
Time frame: November 2004 to August 2007
illnesses requiring visits to healthcare providers.
Time frame: November 2004 to August 2007
6 secondary outcomes
cause specific hospitalizations for diarrhea and acute lower respiratory infections
Time frame: November 2004 to August 2007
cause specific health care provider visits for illness
Time frame: November 2004 to August 2007
all cause mortality in the two groups
Time frame: November 2004 to August 2007
the proportion of stunted or underweight infants at end study
Time frame: November 2004 to August 2007
plasma zinc in a subgroup
Time frame: November 2004 to August 2007
prevalence of diarrheal and respiratory morbidity
Time frame: November 2004 to August 2007
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 3 Sep 2009.
- Results publication: PubMed 19553296Taneja S, Bhandari N, Rongsen-Chandola T, Mahalanabis D, Fontaine O, Bhan MK. Effect of zinc supplementation on morbidity and growth in hospital-born, low-birth-weight infants. Am J Clin Nutr. 2009 Aug;90(2):385-91. doi: 10.3945/ajcn.2009.27707. Epub 2009 Jun 24.
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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.
Nita Bhandari, PhD principal investigator
Society for Applied Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc in people with Diarrhea and Respiratory Infection, run by Society for Applied Studies at 1 site in India.
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 6 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 3 Sep 2009. 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 India. 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?
all cause hospitalizations in comparison to infants receiving placebo. (time frame: November 2004 to August 2007). 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 NCT00272142, 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 3 Sep 2009; AzTrials last refreshed its copy on 8 Nov 2026.