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Completed

NCT Number: NCT00276198

Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

The objective of the program is to examine the efficacy of 6 month home micronutrient supplementation in Bedouin and Jewish children on improvements in nutritional status including measures of iron, ferritin, zinc and folic acid, and measures of growth and health parameters i.e.reported and recorded morbidity.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Communicable Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Infections Infectious Diseases Iron Deficiencies Iron Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Undernutrition

Age range

5 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ministry of Health

Beersheba, 10050, Israel

About this study

The high level of anemia persists in Negev children despite the existence of a policy of the Ministry of Health that calls for Iron, Vitamin A and Vitamin D supplementation up to 12 months of age. In addition, other micronutrient deficiencies in this population have been described in several studies. These may be related to; low adherence with existing recommendations; need for additional micronutrients other than Iron, Vitamin A and Vitamin D; the need for a different delivery system more acceptable to mothers and infants.

We will compare in Bedouin and Jewish children separately the efficacy of daily use of Sprinkles(home Micronutrient fortification) from age 6 to 12 months in infants recruited in Maternal and Child Health clinics.

The comparison will be children recruited in clinics of comparable socioeconomic status, where current Ministry of Health recommendations (drops of iron and vitamins A plus D) are the treatment regimen.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infant aged 5-7 months
  • Infant whose parents give their written informed consent
  • Infants whose parents intend to reside within the area for at least 12 months
  • Infants receiving any additional food besides breast feeding

Exclusion criteria

  • Known or suspected haemotological disorders
  • Known or suspected anemia (Hb <11 gr/dl)
  • Known or suspected immunological disorders
  • Known or suspected malabsorption disorders
  • Enrolled or scheduled to be enrolled in another clinical trial

Treatment and study plan

SPRINKLES

Dietary Supplement

Daily dosage of fat coated iron (desote fumarate) 12.5 mg, zinc 5mg, vitamin A 300 micrograms, folic acid 150 micrograms, ascorbic acid 50 mg.

Ferripel-3, Vitamins A&D drops

Dietary Supplement

Daily dosage of Iron tonic 15mg, vitamins A 300 micrograms, vitamin D 10 micrograms once a day from age 6 months up to age 12 months

Other names: oral drops

Primary outcomes

  1. Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)

    Time frame: 12, 18 and 24 months

  2. Micronutrient status (Iron, Zinc and B12 and Folic acid level)

    Time frame: 12, 18 months

  3. Incidence of infectious diseases total morbidity (IDTM) due to respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever) and all illnesses (ACTM)

    Time frame: 12, 18, 24 months

  4. Health Care Services use (primary care clinics visits, emergency room visits, hospitalizations

    Time frame: 24 months

Secondary outcomes

  1. Reported morbidity due to infectious diseases (lower respiratory tract infections, diarrhea, sepsis, otitis media, cutaneous infections, fever)

    Time frame: 12, 18, 24 months

  2. Growth parameters (WAZ, HAZ, WHZ)

    Time frame: 12, 18, 24 months

  3. Safety, diarrhea, constipation, color, smell and form of stool changes. Any other adverse events.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

Controlled Clinical Trial to Assess the Effect of Multiple Micronutrient Supplementation (Iron, Vitamins A, C, D, Folic Acid and Zinc) on Nutritional and Health Indicators in Infants in Southern Israel.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 13, 2006
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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