AzTrials
AzTrials

Diarrheal IllnessesPhase 3NCT00421668

A Trial of Zinc and Micronutrients in Tanzanian Children

A Phase 3 study testing Zinc and Multivitamins in people with Diarrheal Illnesses and Respiratory Illness, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers. Read more about this study

Who is it for?
Ages 6 weeks to 18 monthsHealthy volunteers can take part
What is being tested?
Zinc and Multivitamins
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,400 participants
Where
1 siteTanzania
Study dates
Sep 2007to Oct 2012
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 6 weeks to 18 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Singleton, live born infants born to HIV- negative women
  • Mothers will need to have registered for pre-natal care before 34 weeks gestation
  • intend to stay in Dar es Salaam for until delivery and 18 months thereafter.

Who cannot join

  • infants born with multiple congenital abnormalities

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

  • Muhimbili Uinverstiy College of Health Sciences

    Dar es Salaam

Other trials in Tanzania

About this study

A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or placebo among 2400 children born to HIV-negative Tanzanian mothers.

Read the detailed description

We propose to study the efficacy of zinc or multiple micronutrient supplementation in reducing the risk of infectious diseases and growth faltering among infants and young children in Tanzania. Infants born to HIV-negative women will be recruited and randomly assigned in a factorial design to either zinc, micronutrients (vitamins C, E, B1, B2, niacin, B6, folate and B12), micronutrients plus zinc, or a placebo given daily. Children will be followed at monthly clinic visits from age 6 weeks for 18 months. Data obtained will include socioeconomic status, anthropometric data (weight, length, head circumference, and arm anthropometrics), dietary intake (including breastfeeding duration and frequency), hemoglobin, ferritin, and blood smear for malaria. The primary outcomes will be the incidence of diarrhea and respiratory tract infections. Secondary outcomes will be weight and length gain. A subset of children will be tested for blood concentrations of vitamin A, E, zinc and C-reactive protein. All children will receive a large periodic dose of vitamin A every 6 months as per standard of care in Tanzania.

Being tested
Zinc, Multivitamins, Placebo
Keywords
HIV, Tanzania, Micronutrients, Infants/children, Infectious Disease, Growth faltering
Medical subject headings
Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZincDrug

    zinc

  • MultivitaminsDrug

    Vitamins C, E, B1, B2, niacin, B6, folate and B12

  • PlaceboDrug

    Placebo

Study groups in NCT00421668
Study groupRoleWhat they receive
MultivitaminsExperimentalVitamins C, E, B1, B2, niacin, B6, folate, and B12
Receives: Drug: Multivitamins
Multivitamins + ZincExperimentalVitamins C, E, B1, B2, niacin, B6, folate and B12, and zinc
Receives: Drug: Zinc; Drug: Multivitamins
ZincExperimentalzinc
Receives: Drug: Zinc
PlaceboPlacebo comparatorplacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of diarrhea

    Measured: from ages 6 weeks to 18 months

  2. respiratory tract infections

    Measured: from ages 6 weeks to 18 months

Secondary outcomes (2)

  1. Weight gain

    Measured: from age 6 weeks to 18 months

  2. Length/height gain

    Measured: from age 6 weeks to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

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
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00421668
Sponsor's protocol ID
HD048969
Status last verified
Mar 2017
First submitted
11 Jan 2007
Last updated
3 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu E, Manji KP, Kirby MA, Kisenge R, Lauer JM, Fawzi WW, Sudfeld CR, Duggan CP. Effects of Zinc Supplementation on Metabolomic Profiles in Tanzanian Infants: A Randomized Trial. J Nutr. 2024 Feb;154(2):403-411. doi: 10.1016/j.tjnut.2023.12.011. Epub 2023 Dec 11.

    PubMed 38092153

  • Rees CA, Kisenge R, Manji KP, Liu E, Fawzi WW, Duggan CP. Identifying Infants and Young Children at Risk of Unplanned Hospital Admissions and Clinic Visits in Dar es Salaam, Tanzania. Pediatr Infect Dis J. 2020 Dec;39(12):e428-e434. doi: 10.1097/INF.0000000000002875.

    PubMed 32842043

  • Lauer JM, McDonald CM, Kisenge R, Aboud S, Fawzi WW, Liu E, Tran HQ, Gewirtz AT, Manji KP, Duggan CP. Markers of Systemic Inflammation and Environmental Enteric Dysfunction Are Not Reduced by Zinc or Multivitamins in Tanzanian Infants: A Randomized, Placebo-Controlled Trial. J Pediatr. 2019 Jul;210:34-40.e1. doi: 10.1016/j.jpeds.2019.02.016. Epub 2019 Apr 2.

    PubMed 30952509

  • Blakstad MM, Smith ER, Etheredge A, Locks LM, McDonald CM, Kupka R, Kisenge R, Aboud S, Bellinger D, Sudfeld CR, Fawzi WW, Manji K, Duggan CP. Nutritional, Socioeconomic, and Delivery Characteristics Are Associated with Neurodevelopment in Tanzanian Children. J Pediatr. 2019 Apr;207:71-79.e8. doi: 10.1016/j.jpeds.2018.10.066. Epub 2018 Dec 14.

    PubMed 30559023

  • Etheredge AJ, Manji K, Kellogg M, Tran H, Liu E, McDonald CM, Kisenge R, Aboud S, Fawzi W, Bellinger D, Gewirtz AT, Duggan CP. Markers of Environmental Enteric Dysfunction Are Associated With Neurodevelopmental Outcomes in Tanzanian Children. J Pediatr Gastroenterol Nutr. 2018 Jun;66(6):953-959. doi: 10.1097/MPG.0000000000001978.

    PubMed 29613921

  • Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.

    PubMed 29472265

  • Locks LM, Mwiru RS, Mtisi E, Manji KP, McDonald CM, Liu E, Kupka R, Kisenge R, Aboud S, Gosselin K, Gillman M, Gewirtz AT, Fawzi WW, Duggan CP. Infant Nutritional Status and Markers of Environmental Enteric Dysfunction are Associated with Midchildhood Anthropometry and Blood Pressure in Tanzania. J Pediatr. 2017 Aug;187:225-233.e1. doi: 10.1016/j.jpeds.2017.04.005. Epub 2017 May 9.

    PubMed 28499715

  • Locks LM, Manji KP, Kupka R, Liu E, Kisenge R, McDonald CM, Aboud S, Wang M, Fawzi WW, Duggan CP. High Burden of Morbidity and Mortality but Not Growth Failure in Infants Exposed to but Uninfected with Human Immunodeficiency Virus in Tanzania. J Pediatr. 2017 Jan;180:191-199.e2. doi: 10.1016/j.jpeds.2016.09.040. Epub 2016 Nov 7.

    PubMed 27829511

  • Locks LM, Manji KP, McDonald CM, Kupka R, Kisenge R, Aboud S, Wang M, Bellinger DC, Fawzi WW, Duggan CP. The effect of daily zinc and/or multivitamin supplements on early childhood development in Tanzania: results from a randomized controlled trial. Matern Child Nutr. 2017 Apr;13(2):e12306. doi: 10.1111/mcn.12306. Epub 2016 May 18.

    PubMed 27189038

  • McDonald CM, Manji KP, Gosselin K, Tran H, Liu E, Kisenge R, Aboud S, Fawzi WW, Gewirtz AT, Duggan CP. Elevations in serum anti-flagellin and anti-LPS Igs are related to growth faltering in young Tanzanian children. Am J Clin Nutr. 2016 Jun;103(6):1548-54. doi: 10.3945/ajcn.116.131409. Epub 2016 Apr 27.

    PubMed 27121948

  • Locks LM, Manji KP, McDonald CM, Kupka R, Kisenge R, Aboud S, Wang M, Fawzi WW, Duggan CP. Effect of zinc and multivitamin supplementation on the growth of Tanzanian children aged 6-84 wk: a randomized, placebo-controlled, double-blind trial. Am J Clin Nutr. 2016 Mar;103(3):910-8. doi: 10.3945/ajcn.115.120055. Epub 2016 Jan 27.

    PubMed 26817503

  • McDonald CM, Manji KP, Kisenge R, Aboud S, Spiegelman D, Fawzi WW, Duggan CP. Daily Zinc but Not Multivitamin Supplementation Reduces Diarrhea and Upper Respiratory Infections in Tanzanian Infants: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Nutr. 2015 Sep;145(9):2153-60. doi: 10.3945/jn.115.212308. Epub 2015 Jul 22.

    PubMed 26203094

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zinc and Multivitamins in people with Diarrheal Illnesses and Respiratory Illness, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

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 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 3 Mar 2017. 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 Tanzania. 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.

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?

Incidence of diarrhea (time frame: from ages 6 weeks to 18 months). 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 NCT00421668, which also lists 12 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 3 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in