Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Hypothesis: Synergistic effect of pre-biotics and iron fortificants will enhance the
      bioavailability of iron; thereby improving the body iron reserves.

      A double blind, randomized controlled trail will be conducted on iron deficient female adults
      (age 18-25 years) in order to determine the synergistic effect of pre-biotics and iron
      fortificants in anemic human subjects. 75 iron deficient females will be randomly divided
      into 5 groups (D0, D1, D2, D3 and D4), each having 15 study subjects and will be given
      varying doses of FeSO4 and NaFeEDTA and Inulin and GOS. Blood samples will be collected from
      overnight fasted women from each group on monthly basis up to three months. Various
      biomarkers for iron absorption, LFTs, RFTs, and Immunoglobulins will be estimated.
    

Detailed description: 
      Study Design A double blind, randomized controlled trial will be used for the purpose of this
      study.

      Study Site The study will be conducted in Islamabad and/or Lahore, depending on the
      availability of the required sample size with the desired profiles.

      Study Duration The trial will last for 12 weeks. Study Population The study population will
      consist of university going iron deficient female adults (age 18-25 years).

      Inclusion and Exclusion Criteria Inclusion Criteria All willing anemic female adults without
      any chronic diseases such as diabetes or hypertension will be included in the study.

      Exclusion Criteria Married females or those with chronic diseases or those already taking
      iron and/or prebiotic supplements will be excluded from the study.

      Sampling Sampling Technique The technique of convenience sampling will be used for the
      current study. Sample Size Each group will consist of 15 study subjects for the purpose of
      convenience and the total sample size will be 75.

      Treatment Plan For this phase of the study, 4 best treatment combinations of pre-biotics
      (Inulin & Galactooligosaccharides) and iron fortificants (FeSO4 and NaFeEDTA) will be chosen.

      Study participants will be randomly chosen to receive either the best treatment combination
      1, 2, 3, 4 or the placebo for 12 weeks on daily basis.

      Efficacy Trials Blood samples will be collected from overnight fasted women from each group
      on monthly basis up to three months. Hematological analysis The collected blood from
      respective groups will be assessed for hematological analysis.

      Iron Biomarkers Obtained sera will also be analyzed for blood serum biomarkers like serum
      iron, folate, ferritin, transferrin saturation fraction & TIBC.

      Liver function tests Liver function tests including AST (Aspartate Aminotransferase), ALT
      (Alanine Aminotransferase), ALP (Alkaline Phosphatase) and Total Bilirubin will be conducted
      Renal function tests Blood urea (GLDH-method) and creatinine (Jaffe-method) levels will be
      determined using commercial kits.

      Immunoglobulins Immunoglobulins, including Immunoglobulin A, Immunoglobulin E, Immunoglobulin
      G, and Immunoglobulin M will be determined using the technique of ELISA (Enzyme linked
      Immunosorbent Assay).
    

Intervention name(s): Prebiotic + Iron Forificant
Intervention type(s): Combination Product
Intervention description(s): A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment