Micronutrients and Child Health Study - Full Text View

Sponsors and Collaborators:	Wageningen University Kilimanjaro Christian Medical Centre, Tanzania
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00623857

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 III

MedlinePlus related topics: Dietary Supplements Malaria Minerals

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Iodine Cadexomer iodine Magnesium Calcium gluconate Vitamin A Retinol Vitamin D Ergocalciferol Selenium Vitamin K Riboflavin Thiamine 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-m- ethylthiazolium chloride, monohydrochloride Ascorbic acid Niacin Niacin hydrochloride

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	600
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Zinc	Dietary Supplement: Zinc Daily oral supplementation with zinc, 10 mg, for an average of 60 weeks
2: Active Comparator 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
3: Active Comparator 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
4: Placebo Comparator 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

Contacts

Contact: Hans Verhoef, PhD	+ 255 787 882596	hans.verhoef@wur.nl
Contact: Raimos M Olomi, MD MMed MPH	+ 255 754 561796	raimosolomi@hotmail.com

Locations

Tanzania
Kilimanjaro Christian Medical Centre	Recruiting
Moshi, Tanzania
Principal Investigator: Hans Verhoef, PhD

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

Responsible Party:	Wageningen University, The Netherlands ( Hans Verhoef )
Study ID Numbers:	WAO 93-442
Study First Received:	February 14, 2008
Last Updated:	March 9, 2008
ClinicalTrials.gov Identifier:	NCT00623857
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

Study placed in the following topic categories:

Malaria
Copper
Vitamin B 6
Tocopherols
Selenium
Nicotinic Acids
Retinol palmitate
Zinc
Iodine
Parasitic Diseases
Protozoan Infections
Tocopherol acetate
Hydroxocobalamin
Ergocalciferols

Thiamine
Vitamin B 12
Alpha-Tocopherol
Folic Acid
Calcium, Dietary
Vitamin E
Vitamin D
Riboflavin
Vitamin A
Vitamin K
Pyridoxine
Iron
Niacin
Ascorbic Acid

Additional relevant MeSH terms:

Coccidiosis
Growth Substances
Physiological Effects of Drugs

Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009