Micronutrients and Child Health Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Malaria	Dietary Supplement: Zinc Dietary Supplement: Vitamins and minerals other than zinc Dietary Supplement: Vitamins plus zinc and other minerals Dietary Supplement: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Effects of Supplementation With Zinc and Other Micronutrients on the Health and Development of African Children

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Calcium Iron Malaria Minerals Vitamin A Vitamin C Vitamin D Vitamin E Vitamin K

Drug Information available for: Pyridoxine hydrochloride Folic acid Thiamine Niacin Pyridoxine Thiamine hydrochloride Cyanocobalamin Riboflavin Thiamine mononitrate Vitamin D Magnesium Iodine Vitamin A Vitamin B Complex Hydroxocobalamin

U.S. FDA Resources

Further study details as provided by Wageningen University:

Primary Outcome Measures:

Febrile malaria episodes [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Haematologic and urinary indicators of micronutrient status [ Time Frame: 30 weeks after start of intervention ] [ Designated as safety issue: Yes ]
Anthropometric indices [ Time Frame: 57 weeks after start of intervention ] [ Designated as safety issue: No ]
T cell immune responses to in vitro stimulation with a crude Plasmodium falciparum lysate [ Time Frame: 30 weeks after start of intervention ] [ Designated as safety issue: No ]
Plasma immunoglobulin concentrations [ Time Frame: 2 weeks after malaria episodes ] [ Designated as safety issue: No ]

Enrollment:	612
Study Start Date:	March 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Zinc	Dietary Supplement: Zinc Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
Active Comparator: 2 Vitamins and minerals other than zinc	Dietary Supplement: 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
Active Comparator: 3 Vitamins plus zinc and other minerals	Dietary Supplement: 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 Comparator: 4 Placebo for all vitamins and minerals	Dietary Supplement: Placebo Daily oral supplementation with placebo for vitamins and all minerals; for an average of 60 weeks

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.

Eligibility

Ages Eligible for Study:	6 Months to 60 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623857

Locations

Tanzania
Kilimanjaro Christian Medical Centre
Moshi, Tanzania

Sponsors and Collaborators

Wageningen University

Kilimanjaro Christian Medical Centre, Tanzania

Investigators

Principal Investigator:	Hans Verhoef, PhD	Wageningen University, Cell Biology and Immunology Group
Study Chair:	Raimos M Olomi, MD MMed MPH	Kilimanjaro Christian Medical Centre
Study Director:	Huub FJ Savelkoul, PhD	Wageningen University, Cell Biology and Immunology Group
Study Director:	John F. Shao, MD	Kilimanjaro Christian Medical Centre

More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2012 Aug 3.

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. Epub 2011 Nov 22.

Responsible Party:	Hans Verhoef, Wageningen University, The Netherlands
ClinicalTrials.gov Identifier:	NCT00623857 History of Changes
Other Study ID Numbers:	WAO 93-442
Study First Received:	February 14, 2008
Last Updated:	March 3, 2010
Health Authority:	Tanzania: National Institute for Medical Research

Keywords provided by Wageningen University:

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

Additional relevant MeSH terms:

Malaria
Protozoan Infections
Parasitic Diseases
Vitamin B 12
Vitamin B 6
Riboflavin
Thiamine
Zinc
Micronutrients
Vitamins

Trace Elements
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

Micronutrients and Child Health Study (MACH)