Micronutrients and Child Health Study

Malaria Clinical Trial

— MACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623857
• Other study ID #: WAO 93-442
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: November 14, 2014
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2014
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 612
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 60 Months

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

Dietary Supplement:
• Zinc
Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
• Vitamins and minerals other than zinc
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
• Vitamins plus zinc and other minerals
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
• Placebo
Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks

Locations

Country	Name	City	State
Tanzania	Kilimanjaro Christian Medical Centre	Moshi

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Kilimanjaro Christian Medical Centre, Tanzania

Country where clinical trial is conducted

Tanzania, 

References & Publications (10)

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 — View 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. — View 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 i — View 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 cro — View 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 — View 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 commun — View Citation

Veenemans J, Jansen EJ, Baidjoe AY, Mbugi EV, Demir AY, Kraaijenhagen RJ, Savelkoul HF, Verhoef H. Effect of a(+)-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. d — View 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 Tr — View 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 micronutr — View 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 r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Febrile malaria episodes		60 weeks	No
Secondary	Haematologic and urinary indicators of micronutrient status		30 weeks after start of intervention	Yes
Secondary	Anthropometric indices		57 weeks after start of intervention	No
Secondary	T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate		30 weeks after start of intervention	No
Secondary	Plasma immunoglobulin concentrations		2 weeks after malaria episodes	No