CompletedPhase 3

Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants

Israel771 participantsStarted 2005-07

Plain-language summary

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.

Who can participate

Age range5 Months – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Haemotological parameters (haemoglobin, transferrin saturation, and ferritin)

Timeframe: 12, 18 and 24 months

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

Timeframe: 12, 18 months

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

Timeframe: 12, 18, 24 months

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

Timeframe: 24 months

Trial details

NCT IDNCT00276198

SponsorSoroka University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-12

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