Sub-clinical Inflammation and Iron Supplementation (SCI&Anaemia)

University of Indonesia (UI)

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Vitamin A group; Dietary Supplement: Iron group; Dietary Supplement: Iron and vitamin A group

Study type: Interventional

Funder types: Other

Identifiers

NCT01198574

SCIVA

Details and patient eligibility

About

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.

Enrollment: 402 patients

Sex: Female

Ages: 12 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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402 participants in 4 patient groups

Iron group

Experimental group

Treatment:

Dietary Supplement: Iron group

Vitamin A group

Experimental group

Description:

Vitamin A group

Treatment:

Dietary Supplement: Vitamin A group

Iron and Vitamin A group

Experimental group

Description:

Iron and Vitamin A group

Treatment:

Dietary Supplement: Iron and vitamin A group

Placebo group

Experimental group

Description:

Placebo group with folic acid

Treatment:

Dietary Supplement: Placebo group