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Diarrheal DisorderPhase 3NCT00133406

Long-term Impact and Intervention for Diarrhea in Brazil

A Phase 3 study testing Glutamine, Vitamin A and glycine in people with Diarrheal Disorder, run by University of Virginia at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Read more about this study

Who is it for?
Ages 2 months to 8 years
Conditions the study is for
Diarrheal Disorder
What is being tested?
Glutamine, Vitamin A and glycine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
1 siteBrazil
Study dates
Jun 2006to Dec 2011
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 2 months to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children ages 2 months to 8 years with height for age Z-score (HAZ) less than the median for the Parque Universitario community. Be a resident in Brazilian flavela. Child's parent or guardian must sign informed consent.

Who cannot join

  • Children exclusively breast-fed. Children who participated in the "hospital study" or any other study with in the past two years. Children with fever > 102 F at time of screening. Children with systemic disease at the time of screening including but not limited to: shock, meningitis, sepsis, pneumonia, tuberculosis, varicella. Children on antibiotics during screening. Children with siblings from the same household enrolled in this study.

Trial locations and contacts

1 site in 1 country.

Richard Guerrant contact

(434) 924-5242

Brazil1 site, 1 recruiting

  • Federal University of Ceará

    Fortaleza, 60436160

    Recruiting

Other trials in Brazil

About this study

The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.

Read the detailed description

Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. Subjects will be enrolled into this prospective, randomized, placebo controlled study of the Long-term Impact and Intervention for Diarrhea in Brazil. Children meeting the inclusion criteria will be prospectively, randomized to four arms: (1) placebo: placebo (2) Vitamin A: Zinc Placebo (3) Vitamin A Placebo:Zinc (4) Vitamin A:Zinc. Intervention will last for one year with two additional years of follow up. A nested study involving all patients will take place at week four. At week four there will be a second randomization to either oral glutamine or glycine (placebo) for an additional ten days. The primary endpoint of the nested study will be the L:M ratio at 6 weeks. The master randomization list will be broken, only by combined approval of the Principal Investigators, at the end of the study or in the unexpected event of a child needing removal from the study (for that case only). All randomized subjects will be visited in their home two times per week for assessment of intercurrent diarrhea. At 1, 4, 8, 12, 24 and 36 months patients will have a nutritional status/anthropometry and diarrheal illness rate assessment. At 0, 1, 1.5, and 4 months all randomized subjects will have a Lactulose:Mannose Ratio (L:M) performed. A blood Zinc and Vitamin A level will be drawn at 0 and 4 months. Also a stool microbiology, lactoferrin and protein loss assessment will be completed at 1 month. All randomized subjects who complete the protocol should have assessments as outlined above at 36 weeks. The primary effect of interest is the difference in mean HAZ changes between children receiving Zinc plus Vitamin A compared to children receiving no Vitamin A or Zinc, averaging the difference in children receiving glutamine and children not receiving glutamine.

Being tested
Glutamine, Vitamin A, glycine, zinc
Keywords
Brazil, Child Nutrition Disorders, Deficiency Diseases
Medical subject headings
Child Nutrition Disorders, Deficiency Diseases

What participants receive

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

  • GlutamineDrug

    0.8gm/kg, ie up to a total daily dose of 16.2gm/day,with juice daily for 10 days

  • Vitamin ADrug

    100,000 IU for children under 12 months of age (or placebo) and PO 200,000 IU for children at least 12 months of age (or placebo), both q months for 1 year at 0, 4 and 8 months.

  • glycineDrug

    0.4gm/kg; ie up to 8.3gm/d, with juice daily for 10 days

  • zincDrug

    40 mg twice weekly for 12 months

Study groups in NCT00133406
Study groupRoleWhat they receive
aExperimentaloral glutamine with juice for 10 days
Receives: Drug: Glutamine
bExperimentalPO vit A q 4 mo for 1 year plus zinc placebo
Receives: Drug: Vitamin A; Drug: zinc
cActive comparatorZinc 40 mg twice weekly Plus Vitamin A Placebo for one year
Receives: Drug: Vitamin A; Drug: zinc
dPlacebo comparatororal glycine with juice daily for 10 days
Receives: Drug: glycine
ePlacebo comparatorVitamin A Placebo plus Zinc Placebo for one year
Receives: Drug: Vitamin A; Drug: zinc
fExperimentalVitamin A q 4 months and PO Zinc for 1 year
Receives: Drug: Vitamin A; Drug: zinc

What is being measured

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

  1. L:M ratio at 1.5 months

    Measured: 1.5 months

Secondary outcomes (3)

  1. L:M ratio at 4 & 12 months

    Measured: 4 and 12 months

  2. HAZ

    Measured: 1.5, 4, 8, 12, 24, and 36 months

  3. Diarrhea burden

    Measured: 4, 8, 12, 24, and 36 months

Timeline

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

  1. First posted23 Aug 2005 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2011 (estimated)

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
321 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00133406
Sponsor's protocol ID
12475
Other IDs
05-0071
Status last verified
Mar 2011
First submitted
19 Aug 2005
Last updated
8 Mar 2011
Results posted
No
Data monitoring committee
No

Publications

  • Lima AA, Anstead GM, Zhang Q, Figueiredo IL, Soares AM, Mota RM, Lima NL, Guerrant RL, Oria RB. Effects of glutamine alone or in combination with zinc and vitamin A on growth, intestinal barrier function, stress and satiety-related hormones in Brazilian shantytown children. Clinics (Sao Paulo). 2014;69(4):225-33. doi: 10.6061/clinics/2014(04)02.

    PubMed 24714829

  • Lima AA, Kvalsund MP, Souza PP, Figueiredo IL, Soares AM, Mota RM, Lima NL, Pinkerton RC, Patrick PP, Guerrant RL, Oria RB. Zinc, vitamin A, and glutamine supplementation in Brazilian shantytown children at risk for diarrhea results in sex-specific improvements in verbal learning. Clinics (Sao Paulo). 2013;68(3):351-8. doi: 10.6061/clinics/2013(03)oa11.

    PubMed 23644855

  • Mitter SS, Oria RB, Kvalsund MP, Pamplona P, Joventino ES, Mota RM, Goncalves DC, Patrick PD, Guerrant RL, Lima AA. Apolipoprotein E4 influences growth and cognitive responses to micronutrient supplementation in shantytown children from northeast Brazil. Clinics (Sao Paulo). 2012;67(1):11-8. doi: 10.6061/clinics/2012(01)03.

    PubMed 22249475

  • Lima AA, Soares AM, Lima NL, Mota RM, Maciel BL, Kvalsund MP, Barrett LJ, Fitzgerald RP, Blaner WS, Guerrant RL. Effects of vitamin A supplementation on intestinal barrier function, growth, total parasitic, and specific Giardia spp infections in Brazilian children: a prospective randomized, double-blind, placebo-controlled trial. J Pediatr Gastroenterol Nutr. 2010 Mar;50(3):309-15. doi: 10.1097/MPG.0b013e3181a96489.

    PubMed 20038852

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glutamine, Vitamin A and glycine in people with Diarrheal Disorder, run by University of Virginia at 1 site in Brazil.

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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Brazil. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Richard Guerrant ((434) 924-5242), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

L:M ratio at 1.5 months (time frame: 1.5 months). 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 NCT00133406, 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 8 Mar 2011.

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