Vitamin A DeficiencyVANCT00674089
Newborn Vitamin A (VA) Supplementation Pilot Project, Pakistan
A study testing Vitamin A in people with Vitamin A Deficiency, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Vitamin A is an essential micronutrient for the normal functioning of the visual system, growth and development, immunity and reproduction. Its deficiency causes anemia, growth retardation and xerophthalmia. Read more about this study
- Who is it for?
- Ages Up to 15 daysHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- Vitamin A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,400 participants
- Where
- 1 sitePakistan
- Study dates
- Jan 2007to Oct 2010
- 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 Up to 15 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Live born infants from all pregnancies within participating villages will be eligible for enrollment in this study.
Who cannot join
- Child born with congenital malformation
- Serious birth injury
- Neonates with birth asphyxia and serious infections
- Gestational age less than 32 weeks
- Birth weight less than 1500 gms
- Refusal by parents to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Vitamin A Supplementation (VAS) as Part of a Neonatal Post Partum Care Package in Rural Pakistan
Vitamin A is an essential micronutrient for the normal functioning of the visual system, growth and development, immunity and reproduction. Its deficiency causes anemia, growth retardation and xerophthalmia. Vitamin A deficiency also increases the incidence and/or severity of infectious episodes and affects child survival. Reduced child survival is the most severe and potentially the most widespread consequence of Vitamin A deficiency. Improvement in vitamin A status is now regarded as one of the most cost effective preventive measures for the reduction of child mortality and morbidity.
Over the past decade several studies have examined the effect of vitamin A on reducing mortality among children aged ≥6months at the time of intervention. Impact of vitamin A supplementation can significantly reduce total mortality but it is only established through supplementation programs in children age 6 months or older. It was assumed that breast milk protects infants from vitamin A deficiency, but recent evidence has challenged this. Infants born with low stores of vitamin A and if the mother breast milk has a low concentration of vitamin A, as found in developing countries, the infants might be unable to meet their daily requirements and improve body reserves. There is association between mortality and degree of vitamin A deficiency, greater the degree of deficiency, higher the mortality.
Read more
The role of vitamin A in child survival is now well established and over 60 countries have vitamin A supplementation programs nationally. However, most are still using vitamin A supplements in the second half of infancy, even though over 75% of all under 5 deaths take place in the first 6 months of life. If neonatal vitamin A supplementation can be found to be effective and a service delivery mechanism also found, this will represent a major advance in reaching the MDG 4 targets. This is thus persuasive reason to explore this particular preventive strategy, especially in terms of packaging with other postnatal care activities. However, given that in some instances it has been difficult to disentangle the effect of vitamin A dosing from concomitant vaccinations such as BCG, the current evidence needs further evaluation in effectiveness settings. We propose to evaluate the effectiveness of early neonatal vitamin A administration (single dose 50,000 units) to the newborn to see its effect on infant mortality less than 6 months of age as part of postnatal package through National Program.
Government has launched the National Program for Family Planning and Primary Health Care since April 1994. Primarily it is being implemented in the community through Lady Health Workers (LHWs) of the National Program.
The LHWs are females, with a minimum of eight years of education, residents of the locality in which they are working. The Programme is being currently implemented in all the districts throughout the country and 93,000 LHWs are working covering primarily women and children of the rural population. These LHWs deliver services related to family planning, maternal and child health, immunization, nutrition and treatment of minor ailments to her average registered population of 100-150 households or ~1000 population. Over 3,000 Supervisors have been recruited and trained to supervise the work of LHWs.
Read the detailed description
Goal:
To reduce the infant mortality rate in rural Pakistan through evidence based interventions.
Aim:
To evaluate the impact of a community-based neonatal Vitamin A supplementation program on the morbidity and mortality in newborns and young infants (1-6 months of age) when administered at community level
Primary objectives:
- To evaluate the effectiveness of a single dose 50,000 IU of vitamin A supplementation to newborn infants within 48 hours after birth in rural Punjab and Sindh in reducing mortality (<6 months of age) by ≥ 25%.
- To evaluate the feasibility of neonatal vitamin A dosing when administered by LHW as part of postnatal care package
Methodology:
Study Design: Community based, cluster randomized, double blinded, placebo control trial
Sample size estimation:
Assuming average infant mortality rate 40 per thousand live births in the proposed clusters without intervention (range 30-50/1000 live births), and a targeted 25% reduction in mortality in first six months of life, (5% significance level and 80% power) our estimates indicate that the trial will require total 360 clusters [180 in each arm]. The average population size and birth rate per LHW are 1000 and 30 respectively Study Site: Districts Sukkhur and Jehlum. Both the districts, represent a typical mix of peri-urban and rural, multiethnic population of Pakistan. Although a public health care infrastructure exists, it is notable that almost 60% of the population seeks care from private health sector. Current rates of immunizations are poor (approximately 60%) and largely population is illiterate.
- Conditions
- Vitamin A Deficiency
- Being tested
- Vitamin A, Placebo
- Keywords
- IMR, Newborn Mortality, Vitamin A Effectiveness, Premature Mortality, Mortality
- Medical subject headings
- Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
Vitamin A 50,000 IU
PlaceboDietary supplement
Vitamin A Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Routine Post-partum Care and Vitamin A supplementation (50,000 IU) to the Newborn Receives: Dietary Supplement: Vitamin A |
| 2 | Placebo comparator | Routine Post-partum Care with Placebo to the Newborn Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is reduction in Infant Mortality less than six months of age
Measured: 2 years
Secondary outcomes (1)
Secondary outcomes includes reduction in the incidence of diarrhea, ARI and Sepsis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJan 2007
- Primary completionOct 2010
- Study completionOct 2010
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 Vitamin A DeficiencyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- John Snow, Inc., Pakistan Ministry of Health, Save the Children, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674089
- Sponsor's protocol ID
- 586-Ped/ERC-06
- Acronym
- VA
- Status last verified
- Oct 2010
- First submitted
- 6 May 2008
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Soofi S, Ariff S, Sadiq K, Habib A, Bhatti Z, Ahmad I, Hussain M, Ali N, Cousens S, Bhutta ZA. Evaluation of the uptake and impact of neonatal vitamin A supplementation delivered through the Lady Health Worker programme on neonatal and infant morbidity and mortality in rural Pakistan: an effectiveness trial. Arch Dis Child. 2017 Mar;102(3):216-223. doi: 10.1136/archdischild-2016-310542. Epub 2016 Jun 28.
PubMed 27471856
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Vitamin A Supplementation (VAS) as Part of a Neonatal Post Partum Care Package in Rural Pakistan
- ClinicalTrials.gov ID
- NCT00674089
- Acronym / sponsor ID
- VA / 586-Ped/ERC-06
- Conditions
- Vitamin A Deficiency
- Keywords
- IMR, Newborn Mortality, Vitamin A Effectiveness, Premature Mortality, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,400 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- John Snow, Inc., Pakistan Ministry of Health, Save the Children, London School of Hygiene and Tropical Medicine
- Study start
- Jan 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 May 2008 (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.
Vitamin A is an essential micronutrient for the normal functioning of the visual system, growth and development, immunity and reproduction. Its deficiency causes anemia, growth retardation and xerophthalmia. Vitamin A deficiency also increases the incidence and/or severity of infectious episodes and affects child survival. Reduced child survival is the most severe and potentially the most widespread consequence of Vitamin A deficiency. Improvement in vitamin A status is now regarded as one of the most cost effective preventive measures for the reduction of child mortality and morbidity.
Over the past decade several studies have examined the effect of vitamin A on reducing mortality among children aged ≥6months at the time of intervention. Impact of vitamin A supplementation can significantly reduce total mortality but it is only established through supplementation programs in children age 6 months or older. It was assumed that breast milk protects infants from vitamin A deficiency, but recent evidence has challenged this. Infants born with low stores of vitamin A and if the mother breast milk has a low concentration of vitamin A, as found in developing countries, the infants might be unable to meet their daily requirements and improve body reserves. There is association between mortality and degree of vitamin A deficiency, greater the degree of deficiency, higher the mortality.
The role of vitamin A in child survival is now well established and over 60 countries have vitamin A supplementation programs nationally. However, most are still using vitamin A supplements in the second half of infancy, even though over 75% of all under 5 deaths take place in the first 6 months of life. If neonatal vitamin A supplementation can be found to be effective and a service delivery mechanism also found, this will represent a major advance in reaching the MDG 4 targets. This is thus persuasive reason to explore this particular preventive strategy, especially in terms of packaging with other postnatal care activities. However, given that in some instances it has been difficult to disentangle the effect of vitamin A dosing from concomitant vaccinations such as BCG, the current evidence needs further evaluation in effectiveness settings. We propose to evaluate the effectiveness of early neonatal vitamin A administration (single dose 50,000 units) to the newborn to see its effect on infant mortality less than 6 months of age as part of postnatal package through National Program.
Government has launched the National Program for Family Planning and Primary Health Care since April 1994. Primarily it is being implemented in the community through Lady Health Workers (LHWs) of the National Program.
The LHWs are females, with a minimum of eight years of education, residents of the locality in which they are working. The Programme is being currently implemented in all the districts throughout the country and 93,000 LHWs are working covering primarily women and children of the rural population. These LHWs deliver services related to family planning, maternal and child health, immunization, nutrition and treatment of minor ailments to her average registered population of 100-150 households or ~1000 population. Over 3,000 Supervisors have been recruited and trained to supervise the work of LHWs.
Detailed description
Goal:
To reduce the infant mortality rate in rural Pakistan through evidence based interventions.
Aim:
To evaluate the impact of a community-based neonatal Vitamin A supplementation program on the morbidity and mortality in newborns and young infants (1-6 months of age) when administered at community level
Primary objectives:
- To evaluate the effectiveness of a single dose 50,000 IU of vitamin A supplementation to newborn infants within 48 hours after birth in rural Punjab and Sindh in reducing mortality (<6 months of age) by ≥ 25%.
- To evaluate the feasibility of neonatal vitamin A dosing when administered by LHW as part of postnatal care package
Methodology:
Study Design: Community based, cluster randomized, double blinded, placebo control trial
Sample size estimation:
Assuming average infant mortality rate 40 per thousand live births in the proposed clusters without intervention (range 30-50/1000 live births), and a targeted 25% reduction in mortality in first six months of life, (5% significance level and 80% power) our estimates indicate that the trial will require total 360 clusters [180 in each arm]. The average population size and birth rate per LHW are 1000 and 30 respectively Study Site: Districts Sukkhur and Jehlum. Both the districts, represent a typical mix of peri-urban and rural, multiethnic population of Pakistan. Although a public health care infrastructure exists, it is notable that almost 60% of the population seeks care from private health sector. Current rates of immunizations are poor (approximately 60%) and largely population is illiterate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Vitamin ARoutine Post-partum Care and Vitamin A supplementation (50,000 IU) to the Newborn |
| 2 | Placebo comparator | Dietary Supplement: PlaceboRoutine Post-partum Care with Placebo to the Newborn |
Who may qualify
- Ages
- Up to 15 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Live born infants from all pregnancies within participating villages will be eligible for enrollment in this study.
Key exclusion criteria (6 listed)
- Child born with congenital malformation
- Serious birth injury
- Neonates with birth asphyxia and serious infections
- Gestational age less than 32 weeks
- Birth weight less than 1500 gms
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 |
|---|---|---|
| Vitamin AVitamin A 50,000 IU | Dietary supplement | 1 |
| PlaceboVitamin A Placebo | Dietary supplement | 2 |
Primary outcome
Primary outcome is reduction in Infant Mortality less than six months of age
Time frame: 2 years
1 secondary outcome
Secondary outcomes includes reduction in the incidence of diarrhea, ARI and Sepsis
Time frame: 2 years
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 10 Aug 2011.
- Derived from this study: PubMed 27471856Soofi S, Ariff S, Sadiq K, Habib A, Bhatti Z, Ahmad I, Hussain M, Ali N, Cousens S, Bhutta ZA. Evaluation of the uptake and impact of neonatal vitamin A supplementation delivered through the Lady Health Worker programme on neonatal and infant morbidity and mortality in rural Pakistan: an effectiveness trial. Arch Dis Child. 2017 Mar;102(3):216-223. doi: 10.1136/archdischild-2016-310542. Epub 2016 Jun 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A in people with Vitamin A Deficiency, run by Aga Khan University at 1 site in Pakistan.
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 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 10 Aug 2011. 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 Pakistan. 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. 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?
Primary outcome is reduction in Infant Mortality less than six months of age (time frame: 2 years). 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 NCT00674089, 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 10 Aug 2011.