Trial Outcomes & Findings for Monitoring and Evaluation of Micronutrients (Sprinkles) Project (NCT NCT00659061)

Results Overview

number with mild to severe anemia (hemoglobin(Hb)\<11g/dL)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

610 participants

Primary outcome timeframe

Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment

Results posted on

2018-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Sprinkle-Advice Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Overall Study STARTED	308	302
Overall Study COMPLETED	287	287
Overall Study NOT COMPLETED	21	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Sprinkle-Advice Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Overall Study Migration due to political unrest	21	15

Baseline Characteristics

Monitoring and Evaluation of Micronutrients (Sprinkles) Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sprinkle-Advice n=308 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=302 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Total n=610 Participants Total of all reporting groups
Age, Continuous	12 months STANDARD_DEVIATION 3.2 • n=5 Participants	12.3 months STANDARD_DEVIATION 3.3 • n=7 Participants	12.2 months STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	172 Participants n=5 Participants	155 Participants n=7 Participants	327 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	147 Participants n=7 Participants	283 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline hemoglobin (Hb) taken at time of enrollment; Endline Hb taken 4-5 months post enrollment

number with mild to severe anemia (hemoglobin(Hb)\<11g/dL)

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=287 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=284 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Number of Participants With Anemia Baseline anemia prevalence	185 participants	172 participants
Number of Participants With Anemia Endline anemia prevalence	139 participants	191 participants

PRIMARY outcome

Timeframe: Baseline Hb taken at time of enrollment; Endline Hb taken 4-5 months post enrollment

number of participants with moderate - severe anemia defined as Hb \< 10g/dL

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=287 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=284 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Number of Participants With Moderate to Severe Anemia Baseline	114 participants	102 participants
Number of Participants With Moderate to Severe Anemia Endline	84 participants	138 participants

PRIMARY outcome

Timeframe: Endline Hb taken 4-5 months post enrollment

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=227 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=264 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Mean Hemoglobin of Participants Post Intervention	10.97 g/dL Interval 10.7 to 11.3	9.98 g/dL Interval 9.7 to 10.2

SECONDARY outcome

Timeframe: Measurement taken 4-5 months post enrollment

Population: those who had endline assessment of serum vitamin A

Categorized as \<20ug/dL; 20-40 ug/dL; \>40 ug/dl

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=232 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=232 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Vitamin A Status of Participants - Post Intervention Low (<20 ug/dl)	74 participants	115 participants
Vitamin A Status of Participants - Post Intervention Moderate (20-40 ug/dl)	96 participants	89 participants
Vitamin A Status of Participants - Post Intervention High (>40 ug/dl)	62 participants	28 participants

SECONDARY outcome

Timeframe: Measurement taken 4-5 months post enrollment

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=277 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=275 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Mean Vitamin A Serum Retinol (ug]dl) Taken Post Intervention	31.8 ug/dl Interval 28.4 to 35.2	25.1 ug/dl Interval 22.5 to 27.8

SECONDARY outcome

Timeframe: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment

Population: those who had complete baseline anthropometric measures

Underweight defined as Weight for Age Z score \< -2 standard deviation (SD)

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=285 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=286 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Percentage of Underweight Participants Baseline Underwt %	49 percentage of participants	48 percentage of participants
Percentage of Underweight Participants Endline Underwt %	35 percentage of participants	44 percentage of participants

SECONDARY outcome

Timeframe: Baseline measurements taken at time of enrollment; Endline measurments taken 4-5 months post enrollment

Population: Those who had complete anthropometric measurements at endline

Stunted defined as Height for Age Z-score \< -2 standard deviation

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=286 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=287 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Percentage of Participants With Stunted Growth Baseline Stunted %	55 percentage of participants	57 percentage of participants
Percentage of Participants With Stunted Growth Endline Stunted %	62 percentage of participants	61 percentage of participants

SECONDARY outcome

Timeframe: Baseline measurements taken at time of enrollment; Endline measurements taken 4-5 months post enrollment

Population: those who had complete anthropometric measurements at endline

Wasted defined as Weight for Height Z-score \< -2SD

Outcome measures

Outcome measures
Measure	Sprinkle-Advice n=284 Participants Sprinkles and age-appropriate feeding advice given by Lady Health Workers (LHWs). Age-appropriate feeding advice is part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.	Advice Only n=286 Participants Age-appropriate feeding advice given by LHWs as part of the standard nutrition messages given by all Lady Health Workers (LHWs) during their community visits.
Percentage of Participants With Wasted Growth Baseline Wasted %	24 percentage of participants	24 percentage of participants
Percentage of Participants With Wasted Growth Endline Wasted %	13 percentage of participants	15 percentage of participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Zulfiqar Ahmed Bhutta

Aga Khan University

Phone: 4930051

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place