NCT00623857

Brief Summary

The purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young Tanzanian children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
612

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

February 14, 2008

Last Update Submit

November 14, 2014

Conditions

Malaria

Keywords

MicronutrientsZincVitaminsTrace elementsMineralsVitamin AVitamin B1Vitamin B2NiacinVitamin B6Folic acidVitamin B12Vitamin CVitamin DVitamin EVitamin KIronIodineCopperSeleniumMagnesiumCalciumMalariaImmunityAnthropometry

Outcome Measures

Primary Outcomes (1)

  • Febrile malaria episodes

    60 weeks

Secondary Outcomes (4)

  • Haematologic and urinary indicators of micronutrient status

    30 weeks after start of intervention

  • Anthropometric indices

    57 weeks after start of intervention

  • T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate

    30 weeks after start of intervention

  • Plasma immunoglobulin concentrations

    2 weeks after malaria episodes

Study Arms (4)

1

ACTIVE COMPARATOR

Zinc

Dietary Supplement: Zinc

2

ACTIVE COMPARATOR

Vitamins and minerals other than zinc

Dietary Supplement: Vitamins and minerals other than zinc

3

ACTIVE COMPARATOR

Vitamins plus zinc and other minerals

Dietary Supplement: Vitamins plus zinc and other minerals

4

PLACEBO COMPARATOR

Placebo for all vitamins and minerals

Dietary Supplement: Placebo

Interventions

ZincDIETARY_SUPPLEMENT

Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks

1
Vitamins and minerals other than zincDIETARY_SUPPLEMENT

Daily supplementation with vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks

2
Vitamins plus zinc and other mineralsDIETARY_SUPPLEMENT

Daily oral supplementation with zinc, vitamin A, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, iron, iodine, copper, selenium, magnesium and calcium; for an average of 60 weeks

3
PlaceboDIETARY_SUPPLEMENT

Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks

4

Eligibility Criteria

Age6 Months - 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 6-60 months
  • Permanently residing in the study area
  • Being moderately or mildly stunted (height-for-age z-score \<-1.5 SD)
  • Informed consent from parents or guardians obtained

You may not qualify if:

  • Severe wasting (weight-for-height z-score \<-3 SD)
  • Hemoglobin concentration \<70 g/L
  • Axillary temperature ≥37.50 °C with malaria antigenemia
  • Signs and symptoms at randomisation suggesting malaria, hepatitis, HIV/AIDS, tuberculosis, sickle cell disease or other severe condition
  • Unable to produce a venous blood sample (\>1 mL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

Related Publications (10)

  • Imwong M, Woodrow CJ, Hendriksen IC, Veenemans J, Verhoef H, Faiz MA, Mohanty S, Mishra S, Mtove G, Gesase S, Seni A, Chhaganlal KD, Day NP, Dondorp AM, White NJ. Plasma concentration of parasite DNA as a measure of disease severity in falciparum malaria. J Infect Dis. 2015 Apr 1;211(7):1128-33. doi: 10.1093/infdis/jiu590. Epub 2014 Oct 24.

    PMID: 25344520RESULT

  • Pasricha SR, Atkinson SH, Armitage AE, Khandwala S, Veenemans J, Cox SE, Eddowes LA, Hayes T, Doherty CP, Demir AY, Tijhaar E, Verhoef H, Prentice AM, Drakesmith H. Expression of the iron hormone hepcidin distinguishes different types of anemia in African children. Sci Transl Med. 2014 May 7;6(235):235re3. doi: 10.1126/scitranslmed.3008249.

    PMID: 24807559RESULT

  • Hendriksen IC, White LJ, Veenemans J, Mtove G, Woodrow C, Amos B, Saiwaew S, Gesase S, Nadjm B, Silamut K, Joseph S, Chotivanich K, Day NP, von Seidlein L, Verhoef H, Reyburn H, White NJ, Dondorp AM. Defining falciparum-malaria-attributable severe febrile illness in moderate-to-high transmission settings on the basis of plasma PfHRP2 concentration. J Infect Dis. 2013 Jan 15;207(2):351-61. doi: 10.1093/infdis/jis675. Epub 2012 Nov 7.

    PMID: 23136222RESULT

  • Veenemans J, Schouten LR, Ottenhof MJ, Mank TG, Uges DR, Mbugi EV, Demir AY, Kraaijenhagen RJ, Savelkoul HF, Verhoef H. Effect of preventive supplementation with zinc and other micronutrients on non-malarial morbidity in Tanzanian pre-school children: a randomized trial. PLoS One. 2012;7(8):e41630. doi: 10.1371/journal.pone.0041630. Epub 2012 Aug 3.

    PMID: 22870238RESULT

  • Veenemans J, Milligan P, Prentice AM, Schouten LR, Inja N, van der Heijden AC, de Boer LC, Jansen EJ, Koopmans AE, Enthoven WT, Kraaijenhagen RJ, Demir AY, Uges DR, Mbugi EV, Savelkoul HF, Verhoef H. Effect of supplementation with zinc and other micronutrients on malaria in Tanzanian children: a randomised trial. PLoS Med. 2011 Nov;8(11):e1001125. doi: 10.1371/journal.pmed.1001125. Epub 2011 Nov 22.

    PMID: 22131908RESULT

  • Veenemans J, Jansen EJ, Baidjoe AY, Mbugi EV, Demir AY, Kraaijenhagen RJ, Savelkoul HF, Verhoef H. Effect of alpha(+)-thalassaemia on episodes of fever due to malaria and other causes: a community-based cohort study in Tanzania. Malar J. 2011 Sep 22;10:280. doi: 10.1186/1475-2875-10-280.

    PMID: 21939508RESULT

  • Veenemans J, Mank T, Ottenhof M, Baidjoe A, Mbugi EV, Demir AY, Wielders JP, Savelkoul HF, Verhoef H. Protection against diarrhea associated with Giardia intestinalis Is lost with multi-nutrient supplementation: a study in Tanzanian children. PLoS Negl Trop Dis. 2011 Jun;5(6):e1158. doi: 10.1371/journal.pntd.0001158. Epub 2011 Jun 7.

    PMID: 21666789RESULT

  • Mbugi EV, Meijerink M, Veenemans J, Jeurink PV, McCall M, Olomi RM, Shao JF, Chilongola JO, Verhoef H, Savelkoul HF. Effect of nutrient deficiencies on in vitro Th1 and Th2 cytokine response of peripheral blood mononuclear cells to Plasmodium falciparum infection. Malar J. 2010 Jun 14;9:162. doi: 10.1186/1475-2875-9-162.

    PMID: 20546583RESULT

  • Mbugi EV, Meijerink M, Veenemans J, Jeurink PV, McCall M, Olomi RM, Shao JF, Verhoef H, Savelkoul HF. Alterations in early cytokine-mediated immune responses to Plasmodium falciparum infection in Tanzanian children with mineral element deficiencies: a cross-sectional survey. Malar J. 2010 May 17;9:130. doi: 10.1186/1475-2875-9-130.

    PMID: 20470442RESULT

  • Veenemans J, Andang'o PE, Mbugi EV, Kraaijenhagen RJ, Mwaniki DL, Mockenhaupt FP, Roewer S, Olomi RM, Shao JF, van der Meer JW, Savelkoul HF, Verhoef H. Alpha+ -thalassemia protects against anemia associated with asymptomatic malaria: evidence from community-based surveys in Tanzania and Kenya. J Infect Dis. 2008 Aug 1;198(3):401-8. doi: 10.1086/589884.

    PMID: 18582194RESULT

MeSH Terms

Conditions

Malaria

Interventions

ZincVitamins

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Hans Verhoef, PhD

    Wageningen University, Cell Biology and Immunology Group

    PRINCIPAL INVESTIGATOR

  • Raimos M Olomi, MD MMed MPH

    Kilimanjaro Christian Medical Centre

    STUDY CHAIR

  • Huub FJ Savelkoul, PhD

    Wageningen University, Cell Biology and Immunology Group

    STUDY DIRECTOR

  • John F. Shao, MD

    Kilimanjaro Christian Medical Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 26, 2008

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

TA(1)