Title

Sub-clinical Inflammation and Iron Supplementation
The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    iron vitamin a ...
  • Study Participants

    402
Anemia and vitamin A deficiency (VAD) are major nutritional problems in the world and also in Myanmar. Both nutrient deficiencies result from interaction of several causal factors, and a better understanding of the etiology to interpret the prevalence and to formulate appropriate measures to reduce these deficiencies is necessary. There is a growing concern on the role of sub-clinical inflammation on the nutritional status indicators during the nutritional status assessment. However, there is lack of information on the role of inflammation on the iron supplementation. The adolescent period is a window of opportunity to improve the preconceptional iron status of the girls and recently gained much attention. The purpose of the study is to understand the role of inflammation on iron and vitamin A status during iron and vitamin A supplementation. The findings will show the extent to which iron supplementation has been hampered by inflammation and to formulate the necessary measures to overcome the interference.
Study Started
Jul 31
2010
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Results Posted
May 16
2012
Estimate
Last Update
May 22
2012
Estimate

Dietary Supplement Iron group

Ferrous fumarate, 60 mg, weekly dose

  • Other names: Iron supplement

Dietary Supplement Vitamin A group

Retinol, weekly dose, 15,000 IU

  • Other names: Vitamin A supplement

Dietary Supplement Iron and vitamin A group

Ferrous fumarate, Retinol combination group, weekly dose

  • Other names: Iron and Vitamin A supplement

Dietary Supplement Placebo group

folic acid only as placebo group

  • Other names: Placebo group, folic acid only

Iron group Experimental

Vitamin A group Experimental

Vitamin A group

Iron and Vitamin A group Experimental

Iron and Vitamin A group

Placebo group Experimental

Placebo group with folic acid

Criteria

Inclusion Criteria:

adolescent girls (age 12-19 years)
already experienced menarche
anemic girls (Hb<120 g/L)
no known illness (apparently healthy)
free from haemoglobinopathy
No regular consumption of iron and vitamin A supplement during the last 3 months

Exclusion Criteria:

subjects with chronic illness
subjects with severe anaemia
who do not give the consents

Summary

Iron Group

Vitamin A Group

Iron and Vitamin A Group

Placebo Group

All Events

Event Type Organ System Event Term

Haemoglobin Level

Haemoglobin level (g/L) measured by cyanmethaemoglobin method

Iron Group

Hb week 0 (Baseline)

88.3
g/L (Mean)
Standard Deviation: 11.2

Hb week 12 (Endline)

110.8
g/L (Mean)
Standard Deviation: 9.8

Hb week 6 (Midline)

98.1
g/L (Mean)
Standard Deviation: 10.6

Vitamin A Group

Hb week 0 (Baseline)

89.2
g/L (Mean)
Standard Deviation: 11.5

Hb week 12 (Endline)

109.0
g/L (Mean)
Standard Deviation: 9.1

Hb week 6 (Midline)

98.7
g/L (Mean)
Standard Deviation: 9.6

Iron and Vitamin A Group

Hb week 0 (Baseline)

88.4
g/L (Mean)
Standard Deviation: 12.1

Hb week 12 (Endline)

111.4
g/L (Mean)
Standard Deviation: 9.0

Hb week 6 (Midline)

99.2
g/L (Mean)
Standard Deviation: 10.0

Placebo Group

Hb week 0 (Baseline)

89.6
g/L (Mean)
Standard Deviation: 12.7

Hb week 12 (Endline)

109.7
g/L (Mean)
Standard Deviation: 8.4

Hb week 6 (Midline)

98.3
g/L (Mean)
Standard Deviation: 10.7

Status of Tissue Iron Store

Tissue iron store was measured by serum ferritin

Iron Group

serum ferritin (Baseline)

32.1
µg/L (Geometric Mean)
Standard Deviation: 2.5

serum ferritin (Endline)

39.6
µg/L (Geometric Mean)
Standard Deviation: 2.1

serum ferritin (Midline)

34.5
µg/L (Geometric Mean)
Standard Deviation: 1.9

Vitamin A Group

serum ferritin (Baseline)

34.4
µg/L (Geometric Mean)
Standard Deviation: 2.6

serum ferritin (Endline)

35.0
µg/L (Geometric Mean)
Standard Deviation: 2.5

serum ferritin (Midline)

32.1
µg/L (Geometric Mean)
Standard Deviation: 2.3

Iron and Vitamin A Group

serum ferritin (Baseline)

25.9
µg/L (Geometric Mean)
Standard Deviation: 3.1

serum ferritin (Endline)

35.4
µg/L (Geometric Mean)
Standard Deviation: 2.4

serum ferritin (Midline)

32.3
µg/L (Geometric Mean)
Standard Deviation: 2.1

Placebo Group

serum ferritin (Baseline)

31.1
µg/L (Geometric Mean)
Standard Deviation: 2.5

serum ferritin (Endline)

28.2
µg/L (Geometric Mean)
Standard Deviation: 2.5

serum ferritin (Midline)

26.5
µg/L (Geometric Mean)
Standard Deviation: 2.3

Status of Cellular Iron Deficiency

Cellular Iron deficiency status is also measured by serum transferrin receptor

Iron Group

serum transferrin receptor (Baseline)

7.09
mg/L (Geometric Mean)
Standard Deviation: 1.52

serum transferrin receptor (Endline)

6.44
mg/L (Geometric Mean)
Standard Deviation: 1.55

serum transferrin receptor (Midline)

6.69
mg/L (Geometric Mean)
Standard Deviation: 1.51

Vitamin A Group

serum transferrin receptor (Baseline)

6.56
mg/L (Geometric Mean)
Standard Deviation: 1.42

serum transferrin receptor (Endline)

6.27
mg/L (Geometric Mean)
Standard Deviation: 1.44

serum transferrin receptor (Midline)

6.39
mg/L (Geometric Mean)
Standard Deviation: 1.41

Iron and Vitamin A Group

serum transferrin receptor (Baseline)

7.16
mg/L (Geometric Mean)
Standard Deviation: 1.59

serum transferrin receptor (Endline)

6.24
mg/L (Geometric Mean)
Standard Deviation: 1.43

serum transferrin receptor (Midline)

6.73
mg/L (Geometric Mean)
Standard Deviation: 1.53

Placebo Group

serum transferrin receptor (Baseline)

6.74
mg/L (Geometric Mean)
Standard Deviation: 1.50

serum transferrin receptor (Endline)

6.61
mg/L (Geometric Mean)
Standard Deviation: 1.54

serum transferrin receptor (Midline)

6.59
mg/L (Geometric Mean)
Standard Deviation: 1.53

Total

402
Participants

Age Continuous

16.0
years (Mean)
Standard Deviation: 1.2

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Iron Group

Vitamin A Group

Iron and Vitamin A Group

Placebo Group

Drop/Withdrawal Reasons

Iron Group

Vitamin A Group

Iron and Vitamin A Group

Placebo Group