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Completed

NCT Number: NCT00276224

Iron Supplementation in Schistosomiasis and Soil Transmitted Helminths Control Programmes in Zambia

The objectives of this study is:

* to establish the coverage rate of weekly iron supplementation in children in intervention schools over a period of nine months * document any side effects of weeekly iron supplementation among children in intervention schools over a period of nine months asses the feasibility of incorporating the weekly iron supplementation programme into the normal school activity in intervention schools determine the extent of acceptability and support for the iron supplementation programme by staff at the health centre nearest to the intervention schools * compare the praziquantel efficacy and schistosomiasis reinfection in children in intervention schools with that of children in control schools following the introduction of weekely iron supplementation over a period of nine months * determine the impact of weekly iron supplementation on haemoglobin levels of children in intervention schools and compare with children in control schools over a period of nine months

Completed

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Key information

Conditions

Schistosomiasis Anaemia Anemia Helminthiases Helminthiasis Hematologic Diseases Hemic and Lymphatic Diseases Infections Parasitic Diseases Trematode Infections Vector Borne Diseases

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenani and Chandwe School

Kenani, Nchelenge district, Zambia

About this study

Iron deficiency anaemia is a common denominator for both schistosomiasis and soil transmitted helminths. Iron deficiency appears to affect the immune response against schistosomes and intestinal helminths. It therefore follows that correcting the iron deficiency anaemia will improve the efficacy of anthelminthics such as praziquantel (against schistosomiasis) and albendazol (against soil transmitted helminths) and ability of the host immune system to resist reinfection with schistosomes and soil transmitted helminths.

The aim of this study is to identify factors necessary for a successful weekly iron supplementation programme in schistosomiasis and soil transmitted helminths control programmes. In addition impact of weekly iron supplementation programme n haemoglobin levels, efficacy of praziquantel, and schistosomiasis re-infection will be studied.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all schoolchildren, in grade 2 and 3, at four selected schools -

Exclusion criteria

-

Treatment and study plan

ferrous sulphate (drug)

Drug

Primary outcomes

  1. Urine samples examined for schistsoma haematobium at month 0, 3. 6 and 9

  2. Stool samples examined for schistsoma mansoni at mont 0, 3, 6 and 9

  3. Blood samples examined for haemoglobin level mont 0 and month 9

Secondary outcomes

  1. Any side effects to iron supplementation, measured every week for the first foru weeks after treatment start. Mesured on:

  2. - headache

  3. nausea

  4. vomiting

  5. body weakness

  6. diarrhoea

  7. abdominal pain

  8. others

Sponsors and collaborators

Lead sponsor

DBL -Institute for Health Research and Development

Other

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Jan 13, 2006
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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