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Micronutrients and Child Health Study (MACH)

Primary Purpose

Malaria

Status

Completed

Phase

Phase 3

Locations

Tanzania

Study Type

Interventional

Intervention

Zinc

Vitamins and minerals other than zinc

Vitamins plus zinc and other minerals

Placebo

About this trial

This is an interventional prevention trial for Malaria focused on measuring Micronutrients, Zinc, Vitamins, Trace elements, Minerals, 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, Calcium, Malaria, Immunity, Anthropometry

Eligibility Criteria

6 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Kilimanjaro Christian Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Zinc

Vitamins and minerals other than zinc

Vitamins plus zinc and other minerals

Placebo for all vitamins and minerals

Outcomes

Primary Outcome Measures

Febrile malaria episodes

Secondary Outcome Measures

Haematologic and urinary indicators of micronutrient status

Anthropometric indices

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

Plasma immunoglobulin concentrations

Full Information

NCT ID

NCT00623857

First Posted

February 14, 2008

Last Updated

November 14, 2014

Sponsor

Wageningen University

Collaborators

Kilimanjaro Christian Medical Centre, Tanzania

1. Study Identification

Unique Protocol Identification Number

NCT00623857

Brief Title

Micronutrients and Child Health Study

Acronym

MACH

Official Title

Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wageningen University

Collaborators

Kilimanjaro Christian Medical Centre, Tanzania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Zinc is essential for the functioning of the immune system. Supplementation trials in Asia, Latin America, the Pacific and developed countries have shown that increasing zinc intake has great potential to control common infections in children, but the response to supplementation may be different in Africa, where the primary environmental challenge to children's health is malaria. Simultaneous supplementation with other potentially limiting nutrients may be required to overcome a lack of response when zinc is given alone. The project aims at measuring effects of daily oral supplementation with zinc and other micronutrients, given either alone or in combination, on malaria incidence and nutritional status, and on indicators of immunity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Micronutrients, Zinc, Vitamins, Trace elements, Minerals, 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, Calcium, Malaria, Immunity, Anthropometry

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

612 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Zinc

Arm Title

Arm Type

Active Comparator

Arm Description

Vitamins and minerals other than zinc

Arm Title

Arm Type

Active Comparator

Arm Description

Vitamins plus zinc and other minerals

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo for all vitamins and minerals

Intervention Type

Dietary Supplement

Intervention Name(s)

Zinc

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamins and minerals other than zinc

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamins plus zinc and other minerals

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Febrile malaria episodes

Time Frame

60 weeks

Secondary Outcome Measure Information:

Title

Haematologic and urinary indicators of micronutrient status

Time Frame

30 weeks after start of intervention

Title

Anthropometric indices

Time Frame

57 weeks after start of intervention

Title

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

Time Frame

30 weeks after start of intervention

Title

Plasma immunoglobulin concentrations

Time Frame

2 weeks after malaria episodes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

60 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Verhoef, PhD

Organizational Affiliation

Wageningen University, Cell Biology and Immunology Group

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Raimos M Olomi, MD MMed MPH

Organizational Affiliation

Kilimanjaro Christian Medical Centre

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Huub FJ Savelkoul, PhD

Organizational Affiliation

Wageningen University, Cell Biology and Immunology Group

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

John F. Shao, MD

Organizational Affiliation

Kilimanjaro Christian Medical Centre

Official's Role

Study Director

Facility Information:

Facility Name

Kilimanjaro Christian Medical Centre

City

Moshi

Country

Tanzania

12. IPD Sharing Statement

Citations:

PubMed Identifier

25344520

Citation

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.

Results Reference

result

PubMed Identifier

24807559

Citation

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.

Results Reference

result

PubMed Identifier

23136222

Citation

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.

Results Reference

result

PubMed Identifier

22870238

Citation

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.

Results Reference

result

PubMed Identifier

22131908

Citation

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.

Results Reference

result

PubMed Identifier

21939508

Citation

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.

Results Reference

result

PubMed Identifier

21666789

Citation

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.

Results Reference

result

PubMed Identifier

20546583

Citation

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.

Results Reference

result

PubMed Identifier

20470442

Citation

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.

Results Reference

result

PubMed Identifier

18582194

Citation

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.

Results Reference

result

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Micronutrients and Child Health Study

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