MalnutritionPhase 2/3NCT00705445
Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan
A Phase 2/3 study testing Micronutrient Supplementation without Zinc, Micronutrient Supplementation with Zinc and Nutritional Counselling and Education in people with Malnutrition and Diarrhea, run by Aga Khan University at 2 sites in Pakistan.
Trial summary
Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. Read more about this study
- Who is it for?
- Ages 2 weeks to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Diarrhea, Pneumonia
- What is being tested?
- Micronutrient Supplementation without Zinc, Micronutrient Supplementation with Zinc and Nutritional Counselling and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,745 participants
- Where
- 2 sitesPakistan
- Study dates
- Nov 2008to Jul 2012
- Phase
- Phase 2/3
- 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 2 weeks to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of ages 2 weeks to 6 months for recruitment into the Trial. Children of ages 6 months and onwards would eligible to receive intervention (in the form of Micronutrient Sprinkles)
Who cannot join
- Children with obvious congenital anomalies.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
The Aga Khan University
Karachi, Sindh, 75300
Project Office, Matiari
Matiari, Sindh, 75300
About this study
Official title: Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.
Read the detailed description
WHO has recommended the use of zinc for the treatment of acute diarrhea. Literature supports up-scaling of zinc supplementation programs to prevent childhood illnesses, such as diarrhea and respiratory infections, and its subsequent co-morbid conditions. As the potential mechanisms of action of zinc still remains to be established, this trial is proposed to evaluate the relationship of intestinal microbial flora, intestinal permeability, morbidity patterns and response to various enteric pathogens in a representative birth cohort randomly allocated to receive daily zinc and micronutrients from 6-18 months of age, and a control population.
- Conditions
- Malnutrition, Diarrhea, Pneumonia, Growth
- Being tested
- Micronutrient Supplementation without Zinc, Micronutrient Supplementation with Zinc, Nutritional Counselling and Education
- Keywords
- Malnutrition, Diarrhea, Pneumonia, Growth, Zinc Supplements, Microbiome
- Medical subject headings
- Malnutrition, Diarrhea, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient Supplementation without ZincDietary supplement
This will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid
Micronutrient Supplementation with ZincDietary supplement
This will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate.
Nutritional Counselling and EducationOther
This will contain Nutritional Counselling and Education.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | This group will not receive any of the intervention supplements. The group will only receive nutritional counselling and education, and treatment provided for any encountered illness according to IMCI guidelines. Receives: Other: Nutritional Counselling and Education |
| B | Experimental | This group will receive micronutrient supplements containing microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid.
This group will also receive Nutritional Counselling and Education and treatment according to IMCI Guidelines for any serious illness. Receives: Dietary Supplement: Micronutrient Supplementation without Zinc |
| C | Experimental | This group will receive Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, Folic Acid, and Zinc.
This group will also receive nutritional counselling, education and treatment according to IMCI Guidelines in case of any untoward illness. Receives: Dietary Supplement: Micronutrient Supplementation with Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.
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 posted26 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2,745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Tufts University
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar ZB Bhutta, MBBS, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705445
- Sponsor's protocol ID
- 752-Peds/ERC-07
- Status last verified
- Aug 2012
- First submitted
- 25 Jun 2008
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balaji V, Dinh DM, Kane AV, Soofi S, Ahmed I, Rizvi A, Chatterjee M, Babji S, Duara J, Moy J, Naumova EN, Wanke CA, Ward HD, Bhutta ZA. Longitudinal Analysis of the Intestinal Microbiota among a Cohort of Children in Rural and Urban Areas of Pakistan. Nutrients. 2023 Feb 28;15(5):1213. doi: 10.3390/nu15051213.
PubMed 36904212Popovic A, Bourdon C, Wang PW, Guttman DS, Soofi S, Bhutta ZA, Bandsma RHJ, Parkinson J, Pell LG. Micronutrient supplements can promote disruptive protozoan and fungal communities in the developing infant gut. Nat Commun. 2021 Nov 18;12(1):6729. doi: 10.1038/s41467-021-27010-3.
PubMed 34795270Ariff S, Krebs NF, Soofi S, Westcott J, Bhatti Z, Tabassum F, Bhutta ZA. Absorbed zinc and exchangeable zinc pool size are greater in Pakistani infants receiving traditional complementary foods with zinc-fortified micronutrient powder. J Nutr. 2014 Jan;144(1):20-6. doi: 10.3945/jn.113.178715. Epub 2013 Nov 13.
PubMed 24225451Soofi S, Cousens S, Iqbal SP, Akhund T, Khan J, Ahmed I, Zaidi AK, Bhutta ZA. Effect of provision of daily zinc and iron with several micronutrients on growth and morbidity among young children in Pakistan: a cluster-randomised trial. Lancet. 2013 Jul 6;382(9886):29-40. doi: 10.1016/S0140-6736(13)60437-7. Epub 2013 Apr 18.
PubMed 23602230
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cluster Randomized Controlled Evaluation of the Impact of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Cohorts of Children in Pakistan
- ClinicalTrials.gov ID
- NCT00705445
- Acronym / sponsor ID
- 752-Peds/ERC-07
- Conditions
- Malnutrition, Diarrhea, Pneumonia, Growth
- Keywords
- Malnutrition, Diarrhea, Pneumonia, Growth, Zinc Supplements, Microbiome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,745 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Tufts University
- Study start
- Nov 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Jun 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.
Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.
Detailed description
WHO has recommended the use of zinc for the treatment of acute diarrhea. Literature supports up-scaling of zinc supplementation programs to prevent childhood illnesses, such as diarrhea and respiratory infections, and its subsequent co-morbid conditions. As the potential mechanisms of action of zinc still remains to be established, this trial is proposed to evaluate the relationship of intestinal microbial flora, intestinal permeability, morbidity patterns and response to various enteric pathogens in a representative birth cohort randomly allocated to receive daily zinc and micronutrients from 6-18 months of age, and a control population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Nutritional Counselling and EducationThis group will not receive any of the intervention supplements. The group will only receive nutritional counselling and education, and treatment provided for any encountered illness according to IMCI guidelines. |
| B | Experimental | Dietary Supplement: Micronutrient Supplementation without ZincThis group will receive micronutrient supplements containing microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. This group will also receive Nutritional Counselling and Education and treatment according to IMCI Guidelines for any serious illness. |
| C | Experimental | Dietary Supplement: Micronutrient Supplementation with ZincThis group will receive Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, Folic Acid, and Zinc. This group will also receive nutritional counselling, education and treatment according to IMCI Guidelines in case of any untoward illness. |
Who may qualify
- Ages
- 2 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children of ages 2 weeks to 6 months for recruitment into the Trial. Children of ages 6 months and onwards would eligible to receive intervention (in the form of Micronutrient Sprinkles)
Key exclusion criteria (1 listed)
- Children with obvious congenital anomalies.
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 |
|---|---|---|
| Micronutrient Supplementation without ZincThis will contain Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D and Folic Acid | Dietary supplement | B |
| Micronutrient Supplementation with ZincThis will contain Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. Additionally, this will also contain 10 mg elemental Zinc Sulphate. | Dietary supplement | C |
| Nutritional Counselling and EducationThis will contain Nutritional Counselling and Education. | Other | A |
Primary outcome
Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.
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 28 Aug 2012.
- Derived from this study: PubMed 36904212Balaji V, Dinh DM, Kane AV, Soofi S, Ahmed I, Rizvi A, Chatterjee M, Babji S, Duara J, Moy J, Naumova EN, Wanke CA, Ward HD, Bhutta ZA. Longitudinal Analysis of the Intestinal Microbiota among a Cohort of Children in Rural and Urban Areas of Pakistan. Nutrients. 2023 Feb 28;15(5):1213. doi: 10.3390/nu15051213.
- Derived from this study: PubMed 34795270Popovic A, Bourdon C, Wang PW, Guttman DS, Soofi S, Bhutta ZA, Bandsma RHJ, Parkinson J, Pell LG. Micronutrient supplements can promote disruptive protozoan and fungal communities in the developing infant gut. Nat Commun. 2021 Nov 18;12(1):6729. doi: 10.1038/s41467-021-27010-3.
- Derived from this study: PubMed 24225451Ariff S, Krebs NF, Soofi S, Westcott J, Bhatti Z, Tabassum F, Bhutta ZA. Absorbed zinc and exchangeable zinc pool size are greater in Pakistani infants receiving traditional complementary foods with zinc-fortified micronutrient powder. J Nutr. 2014 Jan;144(1):20-6. doi: 10.3945/jn.113.178715. Epub 2013 Nov 13.
- Derived from this study: PubMed 23602230Soofi S, Cousens S, Iqbal SP, Akhund T, Khan J, Ahmed I, Zaidi AK, Bhutta ZA. Effect of provision of daily zinc and iron with several micronutrients on growth and morbidity among young children in Pakistan: a cluster-randomised trial. Lancet. 2013 Jul 6;382(9886):29-40. doi: 10.1016/S0140-6736(13)60437-7. Epub 2013 Apr 18.
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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.
Zulfiqar ZB Bhutta, MBBS, PhD principal investigator
Aga Khan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Micronutrient Supplementation without Zinc, Micronutrient Supplementation with Zinc and Nutritional Counselling and Education in people with Malnutrition and Diarrhea, run by Aga Khan University at 2 sites 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 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 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness. (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 NCT00705445, which also lists 4 linked publications.
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 28 Aug 2012.