ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes

This study is currently recruiting participants.
Verified by Johns Hopkins Bloomberg School of Public Health, May 2007

Sponsors and Collaborators: Johns Hopkins Bloomberg School of Public Health
International Centre for Diarrhoeal Disease Research, Bangladesh
United States Agency for International Development (USAID)
Agency for Healthcare Research and Quality (AHRQ)
Information provided by: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00470158
  Purpose

With the long-term public health goal of developing an effective micronutrient supplementation program to improve child health by improving iron and zinc status and decreasing morbidity due to diarrhea in areas with high rates of childhood malnutrition, we seek to determine the most efficacious method of decreasing childhood morbidity and mortality due to diarrhea in toddlers by re-examining the issue of iron and zinc interaction and determining if this interaction can be minimized by separate administration of iron and zinc supplementation.


Condition Intervention Phase
Anemia
Diarrhea
Iron
Drug: iron alternating daily with placebo
Drug: zinc alternating daily with placebo
Drug: iron and zinc combined alternating daily with placebo
Drug: iron alternating daily with zinc
Drug: placebo daily
Phase IV

MedlinePlus related topics:   Anemia    Diarrhea    Dietary Supplements   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:   Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Incidence of Diarrhea [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • change in hemoglobin [ Time Frame: 6 months ]
  • Change in zinc status [ Time Frame: 6 months ]
  • percent anemic [ Time Frame: 6 months ]

Estimated Enrollment:   1000
Study Start Date:   May 2007
Estimated Study Completion Date:   June 2008

Detailed Description:

Iron supplementation is used in reducing anemia and improving hemoglobin status. Zinc supplementation is emerging as possibly an efficacious preventive measure in decreasing incidence of severe diarrhea. Previous studies have suggested interactions of zinc and iron when given together, reducing the effects of supplementation with both minerals. One study in Peru has shown a decrease in interaction effect with separate supplementation of iron and zinc in time when compared to iron administration alone or placebo; however, an evaluation of clinical outcomes and zinc or iron status when iron and zinc are administered separately compared to supplementation of zinc and iron together or each alone has not previously been done. This trial will assess the effect of iron and zinc supplementation given on alternate days compared with giving them together in a combined supplement.

We propose a randomized, double blind, placebo-controlled community trial of children 6-23 months in Mirzapur, Bangladesh. We will recruit and enroll 1000 children 6-23 months old who are permanent residents of the selected villages. Each child will be randomly assigned to 1) daily alternating zinc and placebo 2) daily alternating iron/folic acid and placebo 3) daily alternating zinc/iron/folic acid and placebo 4) daily alternating zinc and iron/folic acid 5) daily placebo. Primary outcomes will include incidence of severe diarrhea, evaluated weekly for 6 months, hemoglobin, prevalence of anemia, and serum zinc.

Analysis of the data will be done to compare the effect of separate iron and zinc supplementation as compared to combined iron and zinc supplementation as well as compared to iron, zinc, or placebo single supplementation. We will evaluate the difference in incidence rate of severe diarrhea, serum hemoglobin, percent anemia, and serum zinc. Since this will be a randomized, double-blind, placebo controlled trial, differences in effect will be most likely explained by the timing of supplement doses. If there is an improvement in clinical and biochemical outcomes, this would be consistent with a decreased interaction of absorption. If no difference is found, there may be another mechanism for the seeming interaction of iron and zinc besides that of mutually inhibitory absorption in the intestine.

  Eligibility
Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Children 6-18 months old
  • Permanent residents of the selected villages

Exclusion Criteria:

  • Severe malnutrition requiring hospitalization (defined as weight for height <-3 SD Z-score)
  • Severe anemia requiring treatment (hemoglobin < 70 g/L)
  • Chronic illness that would impair feeding ability
  • Likely to move in next 6 months.
  • Fever greater than 38.5
  • Regular iron supplementation
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470158

Contacts
Contact: Shams El Arifeen, MBBS, PhD     +880-2-881 0115     shams@icddrb.org    
Contact: Marge Koblinsky, MD, MPH     +(8802) 988 5155     margek@icddrb.org    

Locations
Bangladesh, Mohakhali
ICDDR,B     Recruiting
      Dhaka, Mohakhali, Bangladesh, 1212
      Contact: Shams El Arifeen, MBBS, PhD     +880-2-881 0115     shams@icddrb.org    

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
International Centre for Diarrhoeal Disease Research, Bangladesh
United States Agency for International Development (USAID)
Agency for Healthcare Research and Quality (AHRQ)

Investigators
Principal Investigator:     Robert E Black, MD, MPH     Johns Hopkins Bloomberg School of Public Health    
  More Information

Study ID Numbers:   H.22.05.03.11.C2, GHS-A-00-03-00019-00-90027844
First Received:   May 3, 2007
Last Updated:   May 25, 2007
ClinicalTrials.gov Identifier:   NCT00470158
Health Authority:   United States: Institutional Review Board;   Bangladesh: Ethical Review Committee

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
zinc  
iron  
interaction  
diarrhea  
delivery  

Study placed in the following topic categories:
Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Zinc
Anemia
Iron

Additional relevant MeSH terms:
Growth Substances
Physiological Effects of Drugs
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




Links to all studies - primarily for crawlers