Trial Outcomes & Findings for Is Iron Deficiency the Cause of Anemia Among Women in Cambodia? (NCT NCT02481375)

NCT ID: NCT02481375

Last Updated: 2019-05-14

Results Overview

Marginal means (95% CI) at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters. Multiple imputation was used to impute n=49 missing values for hemoglobin at endline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 809 participants
• Primary outcome timeframe: 12-weeks of intervention
• Results posted on: 2019-05-14

Participant Flow

Participant milestones

Measure	Multiple Micronutrients With Iron Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron. Women will receive the multiple micronutrient with iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine Iron: 12-wk supplementation of iron	Multiple Micronutrients Without Iron This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron. Women will receive the multiple micronutrient without iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine	Iron Only This formulation only has 60 mg elemental iron. Women will receive iron for 12 weeks. Iron: 12-wk supplementation of iron	Placebo This formulation is a placebo. Women will receive a placebo for 12 weeks. Placebo: 12-wk supplementation of placebo
Overall Study STARTED	206	202	201	200
Overall Study COMPLETED	192	191	191	186
Overall Study NOT COMPLETED	14	11	10	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Is Iron Deficiency the Cause of Anemia Among Women in Cambodia?

Baseline characteristics by cohort

Measure	Multiple Micronutrients With Iron n=206 Participants Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron. Women will receive the multiple micronutrient with iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine Iron: 12-wk supplementation of iron	Multiple Micronutrients Without Iron n=202 Participants This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron. Women will receive the multiple micronutrient without iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine	Iron Only n=201 Participants This formulation only has 60 mg elemental iron. Women will receive iron for 12 weeks. Iron: 12-wk supplementation of iron	Placebo n=200 Participants This formulation is a placebo. Women will receive a placebo for 12 weeks. Placebo: 12-wk supplementation of placebo	Total n=809 Participants Total of all reporting groups
Age, Continuous	30 years STANDARD_DEVIATION 8 • n=5 Participants	30 years STANDARD_DEVIATION 8 • n=7 Participants	31 years STANDARD_DEVIATION 8 • n=5 Participants	30 years STANDARD_DEVIATION 8 • n=4 Participants	30 years STANDARD_DEVIATION 8 • n=21 Participants
Sex: Female, Male Female	206 Participants n=5 Participants	202 Participants n=7 Participants	201 Participants n=5 Participants	200 Participants n=4 Participants	809 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Cambodia	206 Participants n=5 Participants	202 Participants n=7 Participants	201 Participants n=5 Participants	200 Participants n=4 Participants	809 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12-weeks of intervention

Marginal means (95% CI) at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters. Multiple imputation was used to impute n=49 missing values for hemoglobin at endline.

Outcome measures

Measure	Multiple Micronutrients With Iron n=206 Participants Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron. Women will receive the multiple micronutrient with iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine Iron: 12-wk supplementation of iron	Multiple Micronutrients Without Iron n=202 Participants This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron. Women will receive the multiple micronutrient without iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine	Iron Only n=201 Participants This formulation only has 60 mg elemental iron. Women will receive iron for 12 weeks. Iron: 12-wk supplementation of iron	Placebo n=200 Participants This formulation is a placebo. Women will receive a placebo for 12 weeks. Placebo: 12-wk supplementation of placebo
Hemoglobin Levels at 12-weeks. Marginal Means (95% CI).	123 g/L Interval 122.0 to 123.0	116 g/L Interval 116.0 to 117.0	121 g/L Interval 120.0 to 121.0	116 g/L Interval 116.0 to 117.0

Adverse Events

Multiple Micronutrients With Iron

Serious events: 138 serious events

Other events: 0 other events

Deaths: 0 deaths

Multiple Micronutrients Without Iron

Serious events: 103 serious events

Other events: 0 other events

Deaths: 0 deaths

Iron Only

Serious events: 101 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 86 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Multiple Micronutrients With Iron n=200 participants at risk Multiple micronutrient formulations were based on the UNICEF/WHO/UNU standard formulation for pregnant and lactating women (UNIMMAP) with increased iron (from 30 mg to 60 mg elemental iron) for comparability to the iron only group (60 mg). This formulation has 15 micronutrients including iron. Women will receive the multiple micronutrient with iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine Iron: 12-wk supplementation of iron	Multiple Micronutrients Without Iron n=195 participants at risk This formulation has the 14 micronutrients included in the UNIMMAP formulation, but does not include iron. Women will receive the multiple micronutrient without iron for 12 weeks. Multiple micronutrients: 12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine	Iron Only n=197 participants at risk This formulation only has 60 mg elemental iron. Women will receive iron for 12 weeks. Iron: 12-wk supplementation of iron	Placebo n=197 participants at risk This formulation is a placebo. Women will receive a placebo for 12 weeks. Placebo: 12-wk supplementation of placebo
Gastrointestinal disorders Adverse side effects (GI distress, constipation, vomiting, diarrhea)	69.0% 138/200 • Number of events 138 • 12-weeks Adverse events were reported as combined (any of the following) - GI distress, constipation, vomiting, and diarrhea.	52.8% 103/195 • Number of events 103 • 12-weeks Adverse events were reported as combined (any of the following) - GI distress, constipation, vomiting, and diarrhea.	51.3% 101/197 • Number of events 101 • 12-weeks Adverse events were reported as combined (any of the following) - GI distress, constipation, vomiting, and diarrhea.	43.7% 86/197 • Number of events 86 • 12-weeks Adverse events were reported as combined (any of the following) - GI distress, constipation, vomiting, and diarrhea.

Other adverse events

Adverse event data not reported

Additional Information

Crystal Karakochuk

University of British Columbia

Phone: 604 822 0421

Email: crystal.karakochuk@ubc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place